CLIA - Tests waived by FDA from January 2000 to present

Tests can be categorized as "waived" from regulatory oversite if they meet certain requirements established by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) law. By selecting a Test System Name, you can view the CLIA data for that Test System, including the corresponding 510(K) record, if applicable. The information is sorted first by the date of Categorization of the Test, then by Test System Name. This list does not include Test Systems that were characterized by the CDC prior to January 2000.

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Show All Test Systems Download Files | More About CLIA
Document	Test System Name Analyte	Analyte Specialty	Effective Date
Infopia Element Blood Glucose Monitoring System
K113670	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/15/2012
LifeSign Status BTA
K974845	Bladder Tumor Associated Antigen	General Immunology	05/15/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer
K120124	Urine Qualitative Dipstick Ketone	Urinalysis	05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer
K120124	Urine Qualitative Dipstick Bilirubin	Urinalysis	05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer
K120124	Urine Qualitative Dipstick Blood	Urinalysis	05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer
K120124	Urine Qualitative Dipstick Glucose	Urinalysis	05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer
K120124	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer
K120124	Urine Qualitative Dipstick Nitrite	Urinalysis	05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer
K120124	Urine Qualitative Dipstick Ph	Urinalysis	05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer
K120124	Urine Qualitative Dipstick Protein	Urinalysis	05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer
K120124	Urine Qualitative Dipstick Urobilinogen	Urinalysis	05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer
K120124	Urine Qualitative Dipstick Specific Gravity	Urinalysis	05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer
K120124	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	05/11/2012
Alere INRatio®2 PT/INR Home Monitoring System  (Prescription Home Use)
K110212	Prothrombin Time (PT)	Hematology	05/08/2012
Alere INRatio®2 PT/INR Monitoring System (Professional Use)  (Professional Use)
K110212	Prothrombin Time (PT)	Hematology	05/08/2012
BioSence Medical Devices, Solus V2 Audible Blood Glucose Monitoring System
K093764	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/08/2012
Dale Medical Products, Inc. RightLevelpH
X120015	Gastric pH	General Chemistry	05/08/2012
Dale Medical Products, Inc. RightSpot pH
X120015	Gastric pH	General Chemistry	05/08/2012
McKesson 120 Urine Analyzer
K120124	Urine Qualitative Dipstick Ketone	Urinalysis	05/08/2012
McKesson 120 Urine Analyzer
K120124	Urine Qualitative Dipstick Bilirubin	Urinalysis	05/08/2012
McKesson 120 Urine Analyzer
K120124	Urine Qualitative Dipstick Blood	Urinalysis	05/08/2012
McKesson 120 Urine Analyzer
K120124	Urine Qualitative Dipstick Glucose	Urinalysis	05/08/2012
McKesson 120 Urine Analyzer
K120124	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/08/2012
McKesson 120 Urine Analyzer
K120124	Urine Qualitative Dipstick Nitrite	Urinalysis	05/08/2012
McKesson 120 Urine Analyzer
K120124	Urine Qualitative Dipstick Ph	Urinalysis	05/08/2012
McKesson 120 Urine Analyzer
K120124	Urine Qualitative Dipstick Protein	Urinalysis	05/08/2012
McKesson 120 Urine Analyzer
K120124	Urine Qualitative Dipstick Urobilinogen	Urinalysis	05/08/2012
McKesson 120 Urine Analyzer
K120124	Urine Qualitative Dipstick Specific Gravity	Urinalysis	05/08/2012
McKesson 120 Urine Analyzer
K120124	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	05/08/2012
Apex Biotechnology Corp. GAL-1E Blood Glucose Monitoring System
K113547	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/30/2012
Germaine Laboratories AimStrip Alcohol Saliva
K093879	Alcohol, Saliva	Toxicology / TDM	04/30/2012
Major Biosystem Corporation, AP-3000 Blood Glucose Monitoring System
K103230	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/30/2012
Major Biosystem Corporation, AP-3000multi Blood Glucose Monitoring System
K103230	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/30/2012
McKesson Urine Reagent Strips
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	04/30/2012
McKesson Urine Reagent Strips
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	04/30/2012
McKesson Urine Reagent Strips
K061559	Urine Qualitative Dipstick Blood	Urinalysis	04/30/2012
McKesson Urine Reagent Strips
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	04/30/2012
McKesson Urine Reagent Strips
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	04/30/2012
McKesson Urine Reagent Strips
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	04/30/2012
McKesson Urine Reagent Strips
K061559	Urine Qualitative Dipstick Ph	Urinalysis	04/30/2012
McKesson Urine Reagent Strips
K061559	Urine Qualitative Dipstick Protein	Urinalysis	04/30/2012
McKesson Urine Reagent Strips
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	04/30/2012
McKesson Urine Reagent Strips
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer
K070929	Urine Qualitative Dipstick Ketone	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer
K070929	Urine Qualitative Dipstick Bilirubin	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer
K070929	Urine Qualitative Dipstick Blood	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer
K070929	Urine Qualitative Dipstick Glucose	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer
K070929	Urine Qualitative Dipstick Leukocytes	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer
K070929	Urine Qualitative Dipstick Nitrite	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer
K070929	Urine Qualitative Dipstick Ph	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer
K070929	Urine Qualitative Dipstick Protein	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer
K070929	Urine Qualitative Dipstick Urobilinogen	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer
K070929	Urine Qualitative Dipstick Specific Gravity	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips
K061559	Urine Qualitative Dipstick Blood	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips
K061559	Urine Qualitative Dipstick Ph	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips
K061559	Urine Qualitative Dipstick Protein	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	04/30/2012
NewScen Coast Bio-Pharmaceutical Co. y.b.t. Pregnancy Test Cassette
K112315	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/30/2012
NewScen Coast Bio-Pharmaceutical Co. y.b.t. Pregnancy Test Strip
K112315	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/30/2012
IND Diagnostic, Inc. Urinary Tract Infection (UTI) Test Strips
K103037	Urine Qualitative Dipstick Leukocytes	Urinalysis	04/25/2012
IND Diagnostic, Inc. Urinary Tract Infection (UTI) Test Strips
K103037	Urine Qualitative Dipstick Nitrite	Urinalysis	04/25/2012
Rapid Pathogen Screening AdenoPlus test  (tear fluid)
K110722	Adenovirus	Virology	04/24/2012
Sofia Analyzer and Influenza A+B FIA {For use with nasal swabs and nasopharyngeal swabs}
K112177	Influenza A/B	Virology	04/20/2012
Medline iFOB One-Step Immunological Fecal Occult Blood Test
K100031	Fecal Occult Blood	General Chemistry	04/19/2012
Acon Laboratories, On-Call Vivid Blood Glucose Monitoring System
K112653	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/18/2012
Fora Care Inc, U-Right TD-4280 Blood Glucose Monitoring System
K113768	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/17/2012
Apex Biotechnology Corporation MEG-2B Blood Glucose Monitoring System
K120448	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/11/2012
Apex Biotechnology Corporation MEG-2B Pro Blood Glucose Monitoring System
K120448	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/11/2012
McKesson Medical-Surgical McKesson hCG Combo Test-Cassette
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/10/2012
McKesson Medical-Surgical, McKesson hCG Urine Test - Cassette
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/10/2012
McKesson Medical-Surgical, McKesson hCG Urine Test - Dipstick
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/10/2012
Medline Industries Medline hCG Urine Pregnancy Test Device
K050741	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/10/2012
Medline Industries Medline hCG Urine Pregnancy Test Strip
K951705	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/10/2012
Bionime USA Corporation Rightest Blood Glucose Monitoring System, Model GM700
K110737	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/05/2012
Diaspect Hemoglobin Measuring System
BK110036	Hemoglobin	Hematology	04/05/2012
Bayer Contour Next Link Wireless Blood Glucose Monitoring System
K110894	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/03/2012
GEMCO Medical, EM50 Self Monitoring Blood Glucose System
K113243	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/03/2012
McKesson H. pylori Test {Whole Blood}
K024350	Helicobacter Pylori Antibodies	General Immunology	04/03/2012
Bayer Contour Link Wireless Blood Glucose Monitoring System
K110587	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/28/2012
McKesson Strep A Test - Twist
K023766	Streptococcus, Group A	Bacteriology	03/23/2012
Mckesson Strep A Test - Dipstick
K010582	Streptococcus, Group A	Bacteriology	03/23/2012
Wondfo Oxycodone Urine Test  (Dip card format)
K113624	Oxycodone	Toxicology / TDM	03/14/2012
Wondfo Oxycodone Urine Test  (Cup format)
K113624	Oxycodone	Toxicology / TDM	03/14/2012
Nova Biomedical Nova Max One Glucose Monitoring System
K112638	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/13/2012
Contour NEXT EZ Blood Glucose Monitoring System
K111268	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/12/2012
Quest Products, Inc. DrugHAWK Home Drug Test
K082898	Amphetamines	Toxicology / TDM	03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test
K082898	Cannabinoids (THC)	Toxicology / TDM	03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test
K082898	Phencyclidine (PCP)	Toxicology / TDM	03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test
K082898	Cocaine Metabolites	Toxicology / TDM	03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test
K082898	Opiates	Toxicology / TDM	03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test
K082898	Methadone	Toxicology / TDM	03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test
K082898	Methamphetamines	Toxicology / TDM	03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test
K082898	Benzodiazepines	Toxicology / TDM	03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test
K082898	Barbiturates	Toxicology / TDM	03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test
K082898	Tricyclic Antidepressants	Toxicology / TDM	03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test
K082898	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test
K082898	Oxycodone	Toxicology / TDM	03/06/2012
Sekisui Diagnostics, LLC OSOM Strep A Test  (direct from throat swab)
K961423	Streptococcus, Group A	Bacteriology	03/01/2012
Tianjin Empecs Medisign MM1000 Blood Glucose Monitoring System
K111456	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/01/2012
Tianjin Empecs Medisign MM1000 Multi-Blood Glucose Monitoring System
K111456	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/01/2012
Tianjin Empecs Medisign MM1100 Blood Glucose Monitoring System
K111456	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/01/2012
Tianjin Empecs Medisign MM1100 Multi-Blood Glucose Monitoring System
K111456	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/01/2012
Tianjin Empecs Medisign MM1200 Blood Glucose Monitoring System
K111456	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/01/2012
Tianjin Empecs Medisign MM1200 Multi-Blood Glucose Monitoring System
K111456	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/01/2012
FreeStyle InsuLinx Blood Glucose Monitoring System
K111874	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/22/2012
Tianjin New Bay Bioresearch Co., Ltd. ForeSure IFOB Dual-Sample Fecal Occult Blood Screen Card Test
K073431	Fecal Occult Blood	General Chemistry	02/22/2012
Sekisui Diagnostics, LLC, OSOM hCG Combo Test
K043385	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/16/2012
Sekisui Diagnostics, LLC, OSOM ImmunoDip Urinary Albumin Test
K022538	Albumin, Urinary	General Chemistry	02/16/2012
Sekisui Diagnostics, LLC, OSOM TRICHOMONAS RAPID TEST
K033864	Trichomonas	Parasitology	02/16/2012
Sekisui Diagnostics, LLC, OSOM ULTRA STREP A
K992658	Streptococcus, Group A	Bacteriology	02/16/2012
Sekisui Diagnostics, LLC, SIGNIFY HCG URINE TEST
K974159	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/16/2012
Sekisui Diagnostics, LLC, SIGNIFY MONO TEST  (For whole blood)
K972231	Infectious Mononucleosis Antibodies (Mono)	General Immunology	02/16/2012
AgaMatrix, Inc. Nugget Blood Glucose Monitoring System
K103544	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/13/2012
ARKRAY ReliOn Prime Blood Glucose Monitoring System
K091102	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/13/2012
Major Biosystem Corp. AP-1010 Blood Glucose Monitoring System
K103044	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/13/2012
Major Biosystem Corp. AP-1010multi Blood Glucose Monitoring System
K103044	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/13/2012
Major Biosystem Corp. AP-1020 Blood Glucose Monitoring System
K103044	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/13/2012
Major Biosystem Corp. AP-1020multi Blood Glucose Monitoring System
K103044	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/13/2012
Delta Products DiaCheck Smart Blood Glucose Monitoring System
K113343	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2012
Delta Products DiaCheck Superior Blood Glucose Monitoring System
K113343	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2012
PSS Consult H. pylori Cassette {Whole Blood, fingerstick only}
K024350	Helicobacter Pylori Antibodies	General Immunology	02/03/2012
Sekisui Diagnostics, LLC OSOM Trichomonas Rapid Test
K033864	Trichomonas	Parasitology	02/03/2012
Sekisui Diagnostics, LLC, OSOM Ultra Srep A Test
K992658	Streptococcus, Group A	Bacteriology	02/03/2012
Apex Biotechnology Corp. GAL-1A Blood Glucose Monitoring System
K113208	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/31/2012
Cambridge Sensors USA microdot Home Blood Glucose Monitoring System
K102383	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/31/2012
Alere Influenza A & B Test {For use with Nasal Swabs only.}
K092349	Influenza A/B	Virology	01/27/2012
Alere iCassette Drug Screen
K050050	Amphetamines	Toxicology / TDM	01/26/2012
Alere iCassette Drug Screen
K050050	Cannabinoids (THC)	Toxicology / TDM	01/26/2012
Alere iCassette Drug Screen
K050050	Phencyclidine (PCP)	Toxicology / TDM	01/26/2012
Alere iCassette Drug Screen
K050050	Cocaine Metabolites	Toxicology / TDM	01/26/2012
Alere iCassette Drug Screen
K050050	Opiates	Toxicology / TDM	01/26/2012
Alere iCassette Drug Screen
K050050	Methamphetamines	Toxicology / TDM	01/26/2012
Diabetic Supply of Suncoast, Inc., Advocate Redi-Code+ Blood Glucose Monitoring System
K102316	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/26/2012
Sekisui Diagnostics, LLC OSOM ImmunoDip Urinary Albumin Test
K022538	Albumin, Urinary	General Chemistry	01/26/2012
Syntron Bioresearch, Inc. URIGE-1 pH Urinalysis Strips
K051727	Urine Qualitative Dipstick Ph	Urinalysis	01/26/2012
Alere Triage MeterPro  (Whole Blood)
K021317	B-Type Natriuretic Peptide (BNP)	General Chemistry	01/23/2012
Simple Diagnostics AG-608N Multi Blood Glucose Montoring System
K110017	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/23/2012
Simple Diagnostics AG-608N Single Blood Glucose Monitoring System
K110017	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/23/2012
TearLab Corporation TearLab Osmolarity System
K083184	Osmolality, Tears	General Chemistry	01/23/2012
Apex Biotechnology Corporation AutoSure Voice II Plus Blood Glucose Monitoring System
K113098	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/19/2012
Major Biosystem Corp. AP-1000multi Blood Glucose Monitoring System
K100437	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/13/2012
Alere San Diego Inc, Alere hCG Cassette (25 mIU/mL)
K993317	hCG, Urine	Endocrinology	01/11/2012
Alere San Diego Inc, Alere hCG Combo Cassette (20/10 mIU/mL)
K062361	hCG, Urine	Endocrinology	01/11/2012
Alere San Diego Inc, Alere hCG Combo Cassette (25 mIU/mL)
K993065	hCG, Urine	Endocrinology	01/11/2012
Alere San Diego Inc, Alere hCG Dipstick (25 mIU/mL)
K993203	hCG, Urine	Endocrinology	01/11/2012
Alere San Diego Inc. Alere hCG Cassette (20 mIU/mL)
K062361	hCG, Urine	Endocrinology	01/11/2012
Fora Care Inc. TD-4257 Blood Glucose Monitoring System
K112963	Glucose	General Chemistry	01/11/2012
Fora Care Inc. TD-4257 Multi Blood Glucose Monitoring System
K112963	Glucose	General Chemistry	01/11/2012
Alfa Scientific Designs Inc. Oral-View Saliva Alcohol Test Strip
K093879	Ethanol (Alcohol)	Toxicology / TDM	01/06/2012
Jant Pharmacal Corporation Accustrip Saliva Alcohol Test Strip
K093879	Ethanol (Alcohol)	Toxicology / TDM	01/06/2012
Roche ACCU-CHEK Nano SmartView Blood Glucose Monitoring System
K113137	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/06/2012
BD Veritor System for Rapid Detection of Flu A + B {For use with nasal swabs and nasopharyngeal swabs} (Includes a Reader)
K112277	Influenza A/B	Virology	01/04/2012
FORA Care, FORA D40d Blood Glucose plus Blood Pressure Monitoring System
K101926	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/04/2012
FORA Care, FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System
K101926	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/04/2012
Gemco Medical EME Pro Self-Monitoring Blood Glucose System
K112901	Glucose Monitoring Devices (Prescription Use Only)	General Chemistry	01/04/2012
Gemco Medical EME Self-Monitoring Blood Glucose System
K112901	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/04/2012
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System
K090405	Triglyceride	General Chemistry	01/04/2012
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System
K090405	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/04/2012
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System
K090405	HDL Cholesterol	General Chemistry	01/04/2012
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System
K090405	Cholesterol	General Chemistry	01/04/2012
VITROLIFE One Step Pregnancy Test Device (urine)
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/04/2012
VITROLIFE One Step Pregnancy Test Device (urine/serum)
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/04/2012
VITROLIFE ONE STEP PREGNANCY TEST STRIP (URINE)
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/04/2012
Fora Care Inc. FORA Premium V10 Blood Glucose Monitoring System
K112275	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/21/2011
Clearview Exact II Influenza A & B Test {For use with Nasal Swabs only.}
K092349	Influenza A/B	Virology	12/16/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen
K041685	Amphetamines	Toxicology / TDM	12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen
K041685	Cannabinoids (THC)	Toxicology / TDM	12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen
K041685	Phencyclidine (PCP)	Toxicology / TDM	12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen
K041685	Cocaine Metabolites	Toxicology / TDM	12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen
K041685	Propoxyphene	Toxicology / TDM	12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen
K041685	Benzodiazepines	Toxicology / TDM	12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen
K041685	Barbiturates	Toxicology / TDM	12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen
K041685	Morphine	Toxicology / TDM	12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen
K041685	Tricyclic Antidepressants	Toxicology / TDM	12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen
K041685	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen
K041685	Oxycodone	Toxicology / TDM	12/14/2011
EPS Bio Technology Corp. Easyplus mini Master Driver Self-Monitoring Blood Glucose Test System
K092887	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/14/2011
Jant Pharmacal Accustrip Value + Pregnancy Urine Test  (Dip-Strip)
K984079	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/13/2011
Stanbio Laboratory, Stanbio alpha One-Step Pregnancy Urine Test  (Dip-Strip)
K984079	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/13/2011
BD Veritor System for Rapid Detection of Flu A + B {For use with nasal and nasopharyngeal swabs} (Includes a Reader)
K112277	Influenza A/B	Virology	12/09/2011
sanofi-aventis U.S. LLC iBGStar Blood Glucose Monitoring System
K103544	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/07/2011
LifeSign, LLC Status H. pylori {OSOM H. pylori} ((for whole blood)
K980798	Helicobacter Pylori Antibodies	General Immunology	12/06/2011
LifeSign, LLC Status Strep A
K983386	Streptococcus, Group A	Bacteriology	12/06/2011
Atlas Medical, ATLAS Home Pregnancy Test (Midstream Format)
K102760	hCG, Urine	Endocrinology	11/28/2011
OraQuick HCV Rapid Antibody Test and OraQuick HCV Visual Reference Panel
P080027	Hepatitis C Virus Antibody	General Immunology	11/28/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test
K071489	Amphetamines	Toxicology / TDM	11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test
K071489	Cannabinoids (THC)	Toxicology / TDM	11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test
K071489	Phencyclidine (PCP)	Toxicology / TDM	11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test
K071489	Cocaine Metabolites	Toxicology / TDM	11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test
K071489	Methadone	Toxicology / TDM	11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test
K071489	Methamphetamines	Toxicology / TDM	11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test
K071489	Benzodiazepines	Toxicology / TDM	11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test
K071489	Barbiturates	Toxicology / TDM	11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test
K071489	Morphine	Toxicology / TDM	11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test
K071489	Tricyclic Antidepressants	Toxicology / TDM	11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test
K071489	Oxycodone	Toxicology / TDM	11/21/2011
Element plus Blood Glucose Monitoring System
K103021	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/08/2011
ARKRAY USA, Inc. DiaScreen Reagent Strips for Urinalysis (Glucose/Ketones)  (Over-The-Counter)
K033851	Urine Qualitative Dipstick Ketone	Urinalysis	11/07/2011
ARKRAY USA, Inc. DiaScreen Reagent Strips for Urinalysis (Glucose/Ketones)  (Over-The-Counter)
K033851	Urine Qualitative Dipstick Glucose	Urinalysis	11/07/2011
Fora Care Inc. TD-4277 Blood Glucose Monitoring System
K100322	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/01/2011
Meijer Distribution Inc, Meijer Premium Blood Glucose Monitoring System
K072413	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/01/2011
Meijer Distribution Inc., Meijer Blood Glucose Monitoring System
K073573	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/01/2011
The Kroger Co., Kroger Premium Blood Glucose Monitoring System
K072413	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/01/2011
Wondfo Cocaine Urine Test  (Dip card format)
K112071	Cocaine Metabolites	Toxicology / TDM	10/31/2011
Wondfo Cocaine Urine Test  (Cup format)
K112071	Cocaine Metabolites	Toxicology / TDM	10/31/2011
Wondfo Methamphetamine Urine Test  (Dip card format)
K112071	Methamphetamines	Toxicology / TDM	10/31/2011
Wondfo Methamphetamine Urine Test  (Cup format)
K112071	Methamphetamines	Toxicology / TDM	10/31/2011
Status iFOBT
K100817	Fecal Occult Blood	General Chemistry	10/19/2011
Acon Laboratories, On-Call Chosen Blood Glucose Monitoring System
K111371	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/17/2011
AK Medical, Glucose Shepherd Blood Glucose Monitoring System
K102316	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/17/2011
AK Medical, Glucose Shepherd Pro Blood Glucose Monitoring System
K102316	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/17/2011
Arkray USA, Glucocard Expression Blood Glucose Monitoring System
K102037	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/11/2011
Fora Care Inc PNC100 Digital Pregnancy Test  (for home use)
K103487	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/06/2011
Fora Care Inc TD-5301 Pregnancy Test  (for home use)
K103487	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/06/2011
Alere HemoPoint H2 Hemoglobin Measurement System
K081719	Hemoglobin	Hematology	10/05/2011
ACCU-CHEK Aviva Plus Blood Glucose Monitoring System
K101299	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/04/2011
Drogueria FMC Distributors, COOL Blood Glucose Monitoring System
K103396	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/04/2011
Teco Diagnostics Saliva Alcohol Test
K111206	Ethanol (Alcohol)	Toxicology / TDM	10/04/2011
Delta Products Corporation DiaCheck Premium Blood Glucose Monitoring System
K100806	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/28/2011
US Diagnostics, Inc. EasyGluco Plus Blood Glucose Monitoring System
K110435	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/28/2011
Wondfo Methylenedioxymethamphetamine Urine Test  (Dip card format)
K112236	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	09/28/2011
Wondfo Methylenedioxymethamphetamine Urine Test  (Cup format)
K112236	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	09/28/2011
Wondfo Morphine Urine Test  (Cup format)
K112236	Morphine	Toxicology / TDM	09/28/2011
Wondfo Morphine Urine Test  (Dip card format)
K112236	Morphine	Toxicology / TDM	09/28/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips
K061559	Urine Qualitative Dipstick Blood	Urinalysis	09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips
K061559	Urine Qualitative Dipstick Ph	Urinalysis	09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips
K061559	Urine Qualitative Dipstick Protein	Urinalysis	09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	09/26/2011
LifeScan OneTouch Verio IQ Blood Glucose Monitoring System
K110637	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/26/2011
Apex Biotechnology Corp. GAL-1C Blood Glucose Monitoring System
K102816	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/20/2011
Clarity iCare Diagnostic LLC, CLARITY Advanced Glucose Monitoring System
K063026	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/20/2011
CoaguSense Prothrombin Time (PT)/INR Monitoring System {Professional Use}
K050243	Prothrombin Time (PT)	Hematology	09/20/2011
GEMCO Medical EM44 Pro Self Monitoring Blood Glucose System
K112272	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/20/2011
GEMCO Medical EM44 Self Monitoring Blood Glucose System
K112272	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/20/2011
Gemco Medical EMV3 Pro Self-Monitoring Blood Glucose System
K111728	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/20/2011
Gemco Medical EMV3 Self-Monitoring Blood Gluose System
K111728	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/20/2011
Merete Medical GmbH pH-EcoCare Comfort Test
X110087	pH, Urine	General Chemistry	09/20/2011
Orient Gene Biotech - One Step Rapid FOB
K110309	Fecal Occult Blood	General Chemistry	09/20/2011
Mediwatch Urinewatch UTI Urinary Tract Infection Test Strips
K063295	Nitrite, Urine	General Chemistry	09/15/2011
Mediwatch Urinewatch UTI Urinary Tract Infection Test Strips
K063295	Leukocyte Esterase, Urinary	Urinalysis	09/15/2011
ACON Laboratories Inc. Mission Saliva Alcohol Test Strip
K093879	Ethanol (Alcohol)	Toxicology / TDM	09/13/2011
Amedica Biotech Instant Test Cup
K082898	Amphetamines	Toxicology / TDM	09/13/2011
Amedica Biotech Instant Test Cup
K082898	Cannabinoids (THC)	Toxicology / TDM	09/13/2011
Amedica Biotech Instant Test Cup
K082898	Phencyclidine (PCP)	Toxicology / TDM	09/13/2011
Amedica Biotech Instant Test Cup
K082898	Cocaine Metabolites	Toxicology / TDM	09/13/2011
Amedica Biotech Instant Test Cup
K082898	Opiates	Toxicology / TDM	09/13/2011
Amedica Biotech Instant Test Cup
K082898	Methadone	Toxicology / TDM	09/13/2011
Amedica Biotech Instant Test Cup
K082898	Methamphetamines	Toxicology / TDM	09/13/2011
Amedica Biotech Instant Test Cup
K082898	Benzodiazepines	Toxicology / TDM	09/13/2011
Amedica Biotech Instant Test Cup
K082898	Barbiturates	Toxicology / TDM	09/13/2011
Amedica Biotech Instant Test Cup
K082898	Tricyclic Antidepressants	Toxicology / TDM	09/13/2011
Amedica Biotech Instant Test Cup
K082898	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	09/13/2011
Amedica Biotech Instant Test Cup
K082898	Oxycodone	Toxicology / TDM	09/13/2011
Apex Biotechnology Corp. Autosure Voice Blood Glucose Monitoring System
K090043	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/13/2011
LifeScan OneTouch Verio Blood Glucose Monitoring System
K093745	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/13/2011
Fora Care Inc. URIGHT TD-4252 Blood Glucose Monitoring System, model TD-4252
K101631	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/09/2011
Simple Diagnostics AG-608 Multi Blood Glucose Montoring System
K102678	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/09/2011
Simple Diagnostics AG-608 Single Blood Glucose Monitoring System
K102678	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/09/2011
Wondfo Methadone Urine Test  (Cup format)
K112310	Methadone	Toxicology / TDM	09/09/2011
Wondfo Methadone Urine Test  (Dip card format)
K112310	Methadone	Toxicology / TDM	09/09/2011
Wondfo Morphine (2000) Urine Test  (Cup format)
K112310	Morphine	Toxicology / TDM	09/09/2011
Wondfo Morphine (2000) Urine Test  (Dip card format)
K112310	Morphine	Toxicology / TDM	09/09/2011
Wondfo Nortriptyline Urine Test  (Cup format)
K112395	Tricyclic Antidepressants	Toxicology / TDM	09/09/2011
Wondfo Nortriptyline Urine Test  (Dip card format)
K112395	Tricyclic Antidepressants	Toxicology / TDM	09/09/2011
Wondfo Phencyclidine Urine Test  (Cup format)
K112395	Phencyclidine (PCP)	Toxicology / TDM	09/09/2011
Wondfo Phencyclidine Urine Test  (Dip card format)
K112395	Phencyclidine (PCP)	Toxicology / TDM	09/09/2011
Apex Biotechnology Corporation MEG-2 Blood Glucose Monitoring System
K101204	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/06/2011
Apex Biotechnology Corporation MEG-2 Multi Blood Glucose Monitoring System
K101204	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/06/2011
Tyson Bio AC100 Blood Glucose Monitoring System
K101543	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/06/2011
Tyson Bio AC100 Pro Blood Glucose Monitoring System
K101543	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/06/2011
Tyson Bio AC200 Blood Glucose Monitoring System
K101543	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/06/2011
Tyson Bio AC200 Pro Blood Glucose Monitoring System
K101543	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/06/2011
Bionime Corporation GE100 Blood Glucose Monitoring System
K092052	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/01/2011
Greenbrier International Inc. Assured Pregnancy Test
K043443	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/26/2011
Alere Cholestech LDX  (Whole Blood)
K032027	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	08/16/2011
Alere Cholestech LDX  (Whole Blood)
K922612	Triglyceride	General Chemistry	08/16/2011
Alere Cholestech LDX  (Whole Blood)
K922612	HDL Cholesterol	General Chemistry	08/16/2011
Alere Cholestech LDX  (Whole Blood)
K922612	Cholesterol	General Chemistry	08/16/2011
Alere Cholestech LDX  (Whole Blood)
K932727	Glucose	General Chemistry	08/16/2011
Alere Cholestech LDX  (Whole Blood)
K991834	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	08/16/2011
Jant Pharmacal Corporation Accustrip Value+ hCG Urine Pregnancy Test Strip
K951705	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/16/2011
MHC Medical Products, LLC. Easy Touch Blood Glucose Monitoring System
K073492	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/16/2011
Simple Diagnostics AG-6081 Multi Blood Glucose Montoring System
K101307	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/16/2011
Simple Diagnostics AG-6081 Single Blood Glucose Monitoring System
K101307	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/16/2011
Simple Diagnostics AG-6951 Multi Blood Glucose Monitoring System
K101307	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/16/2011
Simple Diagnostics AG-6951 Single Blood Glucose Monitoring System
K101307	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/16/2011
Zhejiang Orient Gene Biotech Co. Pregnancy One Step Rapid Test (Cassette)
K103574	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/12/2011
Zhejiang Orient Gene Biotech Co. Pregnancy One Step Rapid Test (Midstream)
K103574	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/12/2011
Zhejiang Orient Gene Biotech Co. Pregnancy One Step Rapid Test (Strip)
K103574	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/12/2011
Greenbrier International, Inc EasySCREEN Marijuana Test Strip
K110182	Cannabinoids (THC)	Toxicology / TDM	08/02/2011
Telcare Blood Glucose Monitoring System
K110571	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/02/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups
K091588	Amphetamines	Toxicology / TDM	07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups
K091588	Cannabinoids (THC)	Toxicology / TDM	07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups
K091588	Cocaine Metabolites	Toxicology / TDM	07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups
K091588	Opiates	Toxicology / TDM	07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups
K091588	Methadone	Toxicology / TDM	07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups
K091588	Methamphetamines	Toxicology / TDM	07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups
K091588	Benzodiazepines	Toxicology / TDM	07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups
K091588	Barbiturates	Toxicology / TDM	07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups
K091588	Morphine	Toxicology / TDM	07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups
K091588	Oxycodone	Toxicology / TDM	07/21/2011
UCP Biosciences, Inc. U-Checker Home Drug Screening Test Cups
K091588	Phencyclidine (PCP)	Toxicology / TDM	07/21/2011
UCP Biosciences, Inc. U-Checker Home Drug Screening Test Cups
K091588	Tricyclic Antidepressants	Toxicology / TDM	07/21/2011
Andon Medical Co., Ltd. AG-695 Multi Blood Glucose Monitoring System
K093755	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/20/2011
Andon Medical Co., Ltd. AG-695 Single Blood Glucose Monitoring System
K093755	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/20/2011
Andon Medical Co., Ltd. AG-696 Multi Blood Glucose Monitoring System
K093755	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/20/2011
Andon Medical Co., Ltd. AG-696 Single Blood Glucose Monitoring System
K093755	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/20/2011
Heritage House '76 Inc. Quick & Clear hCG Urine Pregancy Tests  (Cassette)
K043443	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/20/2011
Wondfo Amphetamine Urine Test
K111560	Amphetamines	Toxicology / TDM	07/20/2011
Wondfo Oxazepam Urine Test
K111560	Benzodiazepines	Toxicology / TDM	07/20/2011
Wondfo Secobarbital Urine Test
K111560	Barbiturates	Toxicology / TDM	07/20/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)
K070009	Amphetamines	Toxicology / TDM	07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)
K070009	Cannabinoids (THC)	Toxicology / TDM	07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)
K070009	Phencyclidine (PCP)	Toxicology / TDM	07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)
K070009	Cocaine Metabolites	Toxicology / TDM	07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)
K070009	Opiates	Toxicology / TDM	07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)
K070009	Methadone	Toxicology / TDM	07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)
K070009	Methamphetamines	Toxicology / TDM	07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)
K070009	Benzodiazepines	Toxicology / TDM	07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)
K070009	Barbiturates	Toxicology / TDM	07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)
K070009	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)
K070009	Oxycodone	Toxicology / TDM	07/19/2011
Great Lakes Medical Trading Accurate Diagnostics Pregnancy Test Strip
K951705	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/14/2011
Independent Medical Co-op. Inc. IMCO Pregnancy Test
K951705	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/14/2011
Jant Pharmacal Accutest Value+ hCG Serum/Urine Pregnancy Test Device
K974009	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Blood	Urinalysis	07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Ph	Urinalysis	07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Protein	Urinalysis	07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Ketone	Urinalysis	07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Bilirubin	Urinalysis	07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Blood	Urinalysis	07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Glucose	Urinalysis	07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Leukocytes	Urinalysis	07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Nitrite	Urinalysis	07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Ph	Urinalysis	07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Protein	Urinalysis	07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Urobilinogen	Urinalysis	07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Specific Gravity	Urinalysis	07/14/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test
K041685	Amphetamines	Toxicology / TDM	07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test
K041685	Cannabinoids (THC)	Toxicology / TDM	07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test
K041685	Phencyclidine (PCP)	Toxicology / TDM	07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test
K041685	Cocaine Metabolites	Toxicology / TDM	07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test
K041685	Opiates	Toxicology / TDM	07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test
K041685	Propoxyphene	Toxicology / TDM	07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test
K041685	Benzodiazepines	Toxicology / TDM	07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test
K041685	Barbiturates	Toxicology / TDM	07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test
K041685	Tricyclic Antidepressants	Toxicology / TDM	07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test
K041685	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test
K041685	Oxycodone	Toxicology / TDM	07/07/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Amphetamines	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Cannabinoids (THC)	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Phencyclidine (PCP)	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Cocaine Metabolites	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Opiates	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Methadone	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Methamphetamines	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Benzodiazepines	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Barbiturates	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Morphine	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Tricyclic Antidepressants	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards
K091588	Oxycodone	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Amphetamines	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Cannabinoids (THC)	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Phencyclidine (PCP)	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Cocaine Metabolites	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Opiates	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Methadone	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Methamphetamines	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Benzodiazepines	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Barbiturates	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Morphine	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Tricyclic Antidepressants	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups
K110515	Oxycodone	Toxicology / TDM	06/30/2011
Fora Care Inc., Fora GD40a/b Blood Glucose Monitoring System
K101509	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/29/2011
Fora Care Inc., Fora Wisdom GD40a/b Blood Glucose Monitoring System
K101509	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/29/2011
Fora Care Inc., U-Right TD-4279A/B Blood Glucose Monitoring System
K101509	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/29/2011
Fora Care Inc., U-Right TD-4279A/B MULTI Blood Glucose Monitoring System
K101509	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/29/2011
Binax Clearview Advanced Strep A {direct from throat swab}
K091489	Streptococcus, Group A	Bacteriology	06/24/2011
EPS Bio Technology Corp EasyMax T1 Pro Self-Monitoring Blood Glucose System
K102345	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/23/2011
EPS Bio Technology Corp EasyMax T1 Self-Monitoring Blood Glucose System
K102345	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/23/2011
IND Diagnostic Inc. One Step hCG Urine Pregnancy Test (Strip)
K110889	hCG, Urine	Endocrinology	06/23/2011
Alere NMP22 BladderChek Test {Prescription Home Use}
K021231	Bladder Tumor Associated Antigen	General Immunology	06/22/2011
Alere NMP22 BladderChek Test {Professional Use}
K021231	Bladder Tumor Associated Antigen	General Immunology	06/22/2011
Alere, INRatio 2 PT/INR Monitoring System  (Professional Use)
K072727	Prothrombin Time (PT)	Hematology	06/22/2011
PSS World Medical, Inc., Quintet AC Blood Glucose Monitoring System
K092052	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/22/2011
Insight Medical Drug of Abuse Urine Cassette Test
K100051	Morphine	Toxicology / TDM	06/17/2011
Insight Medical Drug of Abuse Urine Cassette Test
K100051	Oxycodone	Toxicology / TDM	06/17/2011
Insight Medical Drug of Abuse Urine Cup Test
K100051	Morphine	Toxicology / TDM	06/17/2011
Insight Medical Drug of Abuse Urine Cup Test
K100051	Oxycodone	Toxicology / TDM	06/17/2011
Instant Technologies, Inc. iScreen Drug of Abuse Urine (Cassette) Test
K100051	Morphine	Toxicology / TDM	06/17/2011
Instant Technologies, Inc. iScreen Drug of Abuse Urine (Cassette) Test
K100051	Oxycodone	Toxicology / TDM	06/17/2011
Instant Technologies, Inc. iScreen Drug of Abuse Urine (Cup) Test
K100051	Morphine	Toxicology / TDM	06/17/2011
Instant Technologies, Inc. iScreen Drug of Abuse Urine (Cup) Test
K100051	Oxycodone	Toxicology / TDM	06/17/2011
Jant Pharmacal AccutestDrug of Abuse Urine (Cassette) Test
K100051	Morphine	Toxicology / TDM	06/17/2011
Jant Pharmacal AccutestDrug of Abuse Urine (Cassette) Test
K100051	Oxycodone	Toxicology / TDM	06/17/2011
Jant Pharmacal AccutestDrug of Abuse Urine (Cup) Test
K100051	Morphine	Toxicology / TDM	06/17/2011
Jant Pharmacal AccutestDrug of Abuse Urine (Cup) Test
K100051	Oxycodone	Toxicology / TDM	06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Amphetamines	Toxicology / TDM	06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Cannabinoids (THC)	Toxicology / TDM	06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Phencyclidine (PCP)	Toxicology / TDM	06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Cocaine Metabolites	Toxicology / TDM	06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Opiates	Toxicology / TDM	06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Methadone	Toxicology / TDM	06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Methamphetamines	Toxicology / TDM	06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Benzodiazepines	Toxicology / TDM	06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Barbiturates	Toxicology / TDM	06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Tricyclic Antidepressants	Toxicology / TDM	06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup
K082898	Oxycodone	Toxicology / TDM	06/17/2011
Total Diagnostic Solutions Drug of Abuse Urine (Cassette) Test
K100051	Morphine	Toxicology / TDM	06/17/2011
Total Diagnostic Solutions Drug of Abuse Urine (Cassette) Test
K100051	Oxycodone	Toxicology / TDM	06/17/2011
Total Diagnostic Solutions Drug of Abuse Urine (Cup) Test
K100051	Morphine	Toxicology / TDM	06/17/2011
Total Diagnostic Solutions Drug of Abuse Urine (Cup) Test
K100051	Oxycodone	Toxicology / TDM	06/17/2011
Saless Enterprises New Choice Ovulation Urine Test (Cassette)
X110078	Luteinizing Hormone (LH)	Endocrinology	06/14/2011
Simple Diagnostics. Clever Choice Voice+ Blood Glucose Monitoring System
K102049	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/06/2011
Medline EvenCare G2 Blood Glucose Monitoring System
K102037	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/03/2011
BTNX Rapid Response U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Chemistries	Urinalysis	06/02/2011
BTNX Rapid Response Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Chemistries	Urinalysis	06/02/2011
EPS Bio Technology Corp EG V1 Pro Self-Monitoring Blood Glucose System
K101037	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/02/2011
EPS Bio Technology Corp EG V1(BL) Self-Monitoring Blood Glucose System
K101037	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/02/2011
SCI International, Inc. U-Check Pregnancy Test (Strip Format)
K062703	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/02/2011
Wondfo Cannabinoids Urine Test
K110182	Cannabinoids (THC)	Toxicology / TDM	06/02/2011
Proctor and Gamble Clearblue Plus Pregnancy Test
K110433	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/13/2011
Saless Enterprises Inc. New Choice Pregnancy Test (cassette)
K043443	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/12/2011
Saless Enterprises Inc. Pregnancy Test (strip)
K043443	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/12/2011
Saless Enterprises Inc. U-Check Pregnancy Test (cassette)
K043443	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/12/2011
Saless Enterprises Inc. U-Check Pregnancy Test (strip)
K043443	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/12/2011
Saless Eterprises Inc. Baby Test Pregnancy Test (cassette)
K043443	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/12/2011
SMC Direct Inc. RefuAH One Step HCG Urine Test (cassette)
K043443	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/12/2011
SMC Direct Inc. RefuAH One Step HCG Urine Test (strip)
K043443	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/12/2011
Apex BioTechnology Corp. AutoSure Voice 3 Blood Glucose Monitoring System
K102481	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115	Amphetamines	Toxicology / TDM	05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115	Cannabinoids (THC)	Toxicology / TDM	05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115	Phencyclidine (PCP)	Toxicology / TDM	05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115	Cocaine Metabolites	Toxicology / TDM	05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115	Opiates	Toxicology / TDM	05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115	Methadone	Toxicology / TDM	05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115	Methamphetamines	Toxicology / TDM	05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115	Benzodiazepines	Toxicology / TDM	05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115	Barbiturates	Toxicology / TDM	05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115	Tricyclic Antidepressants	Toxicology / TDM	05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115	Oxycodone	Toxicology / TDM	05/05/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Amphetamines	Toxicology / TDM	04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Cannabinoids (THC)	Toxicology / TDM	04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Phencyclidine (PCP)	Toxicology / TDM	04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Cocaine Metabolites	Toxicology / TDM	04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Opiates	Toxicology / TDM	04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Methadone	Toxicology / TDM	04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Methamphetamines	Toxicology / TDM	04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Benzodiazepines	Toxicology / TDM	04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Barbiturates	Toxicology / TDM	04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Morphine	Toxicology / TDM	04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Tricyclic Antidepressants	Toxicology / TDM	04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups
K091588	Oxycodone	Toxicology / TDM	04/22/2011
Owens & Minor, MediChoice hCG Combi Cassette
K041728	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/22/2011
Owens & Minor, MediChoice hCG Urine Cassette
K041728	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Amphetamines	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Cannabinoids (THC)	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Phencyclidine (PCP)	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Cocaine Metabolites	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Opiates	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Methadone	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Methamphetamines	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Benzodiazepines	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Barbiturates	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Morphine	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Tricyclic Antidepressants	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups
K110515	Oxycodone	Toxicology / TDM	04/22/2011
ProAdvantage by NDC Strep A Test
K010582	Streptococcus, Group A	Bacteriology	04/21/2011
Siemens Albustix Reagent Strips for Urinalysis
X100048	Urine Qualitative Dipstick Protein	Urinalysis	04/21/2011
Immunostics Inc. Detector UriStrip IDU-10
K970250	Urine Qualitative Dipstick Ketone	Urinalysis	04/15/2011
Immunostics Inc. Detector UriStrip IDU-10
K970250	Urine Qualitative Dipstick Bilirubin	Urinalysis	04/15/2011
Immunostics Inc. Detector UriStrip IDU-10
K970250	Urine Qualitative Dipstick Blood	Urinalysis	04/15/2011
Immunostics Inc. Detector UriStrip IDU-10
K970250	Urine Qualitative Dipstick Glucose	Urinalysis	04/15/2011
Immunostics Inc. Detector UriStrip IDU-10
K970250	Urine Qualitative Dipstick Leukocytes	Urinalysis	04/15/2011
Immunostics Inc. Detector UriStrip IDU-10
K970250	Urine Qualitative Dipstick Nitrite	Urinalysis	04/15/2011
Immunostics Inc. Detector UriStrip IDU-10
K970250	Urine Qualitative Dipstick Ph	Urinalysis	04/15/2011
Immunostics Inc. Detector UriStrip IDU-10
K970250	Urine Qualitative Dipstick Protein	Urinalysis	04/15/2011
Immunostics Inc. Detector UriStrip IDU-10
K970250	Urine Qualitative Dipstick Urobilinogen	Urinalysis	04/15/2011
Immunostics Inc. Detector UriStrip IDU-10
K970250	Urine Qualitative Dipstick Specific Gravity	Urinalysis	04/15/2011
Mediwatch USA urinewatch Urine Strips
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	04/15/2011
Mediwatch USA urinewatch Urine Strips
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	04/15/2011
Mediwatch USA urinewatch Urine Strips
K061559	Urine Qualitative Dipstick Blood	Urinalysis	04/15/2011
Mediwatch USA urinewatch Urine Strips
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	04/15/2011
Mediwatch USA urinewatch Urine Strips
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	04/15/2011
Mediwatch USA urinewatch Urine Strips
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	04/15/2011
Mediwatch USA urinewatch Urine Strips
K061559	Urine Qualitative Dipstick Ph	Urinalysis	04/15/2011
Mediwatch USA urinewatch Urine Strips
K061559	Urine Qualitative Dipstick Protein	Urinalysis	04/15/2011
Mediwatch USA urinewatch Urine Strips
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	04/15/2011
Mediwatch USA urinewatch Urine Strips
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	04/15/2011
Mediwatch USA urinewatch Urine Strips
K061559	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	04/15/2011
Stanbio RELY H. pylori Rapid Test (Whole Blood) {Finger-stick only}
K024350	Helicobacter Pylori Antibodies	General Immunology	04/07/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115	Amphetamines	Toxicology / TDM	03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115	Cannabinoids (THC)	Toxicology / TDM	03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115	Phencyclidine (PCP)	Toxicology / TDM	03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115	Cocaine Metabolites	Toxicology / TDM	03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115	Opiates	Toxicology / TDM	03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115	Methadone	Toxicology / TDM	03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115	Methamphetamines	Toxicology / TDM	03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115	Benzodiazepines	Toxicology / TDM	03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115	Barbiturates	Toxicology / TDM	03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115	Tricyclic Antidepressants	Toxicology / TDM	03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115	Oxycodone	Toxicology / TDM	03/24/2011
Mediwatch urinewatch Urine Analyzer
K070929	Urine Qualitative Dipstick Ketone	Urinalysis	03/24/2011
Mediwatch urinewatch Urine Analyzer
K070929	Urine Qualitative Dipstick Bilirubin	Urinalysis	03/24/2011
Mediwatch urinewatch Urine Analyzer
K070929	Urine Qualitative Dipstick Blood	Urinalysis	03/24/2011
Mediwatch urinewatch Urine Analyzer
K070929	Urine Qualitative Dipstick Glucose	Urinalysis	03/24/2011
Mediwatch urinewatch Urine Analyzer
K070929	Urine Qualitative Dipstick Leukocytes	Urinalysis	03/24/2011
Mediwatch urinewatch Urine Analyzer
K070929	Urine Qualitative Dipstick Nitrite	Urinalysis	03/24/2011
Mediwatch urinewatch Urine Analyzer
K070929	Urine Qualitative Dipstick Ph	Urinalysis	03/24/2011
Mediwatch urinewatch Urine Analyzer
K070929	Urine Qualitative Dipstick Protein	Urinalysis	03/24/2011
Mediwatch urinewatch Urine Analyzer
K070929	Urine Qualitative Dipstick Urobilinogen	Urinalysis	03/24/2011
Mediwatch urinewatch Urine Analyzer
K070929	Urine Qualitative Dipstick Specific Gravity	Urinalysis	03/24/2011
OC-Light iFOB Test
K041297	Fecal Occult Blood	General Chemistry	03/24/2011
Clearview COMPLETE HIV 1/2  (Fingerstick and venous whole blood)
BP050009	HIV-1 and HIV-2 Antibodies	General Immunology	03/17/2011
Clearview HIV1/2 STAT-PAK  (Fingerstick and venous whole blood)
BP050010	HIV-1 and HIV-2 Antibodies	General Immunology	03/17/2011
Siemens Combistix Reagent Strips
K905396	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	02/25/2011
Siemens Hema-Combistix Reagent Strips
K905396	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	02/25/2011
Siemens Hemastix Reagent Strips
K905396	Urine Qualitative Dipstick Blood	Urinalysis	02/25/2011
Siemens Uristix 4 Reagent Strips
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	02/25/2011
Siemens Uristix 4 Reagent Strips
K992257	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/25/2011
Siemens Uristix 4 Reagent Strips
K992257	Urine Qualitative Dipstick Nitrite	Urinalysis	02/25/2011
Siemens Uristix 4 Reagent Strips
K992257	Urine Qualitative Dipstick Protein	Urinalysis	02/25/2011
Siemens Uristix Reagent Strips
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	02/25/2011
Siemens Uristix Reagent Strips
K992257	Urine Qualitative Dipstick Protein	Urinalysis	02/25/2011
TECO DIAGNOSTICS UTI Test Strips
K100024	Urine Qualitative Dipstick Nitrite	Urinalysis	02/25/2011
TECO DIAGNOSTICS UTI Test Strips
K100024	Leukocyte Esterase, Urinary	Urinalysis	02/25/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer
K070929	Urine Qualitative Dipstick Ketone	Urinalysis	02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer
K070929	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer
K070929	Urine Qualitative Dipstick Blood	Urinalysis	02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer
K070929	Urine Qualitative Dipstick Glucose	Urinalysis	02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer
K070929	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer
K070929	Urine Qualitative Dipstick Nitrite	Urinalysis	02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer
K070929	Urine Qualitative Dipstick Ph	Urinalysis	02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer
K070929	Urine Qualitative Dipstick Protein	Urinalysis	02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer
K070929	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer
K070929	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/14/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Glucose	Urinalysis	02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Ketone	Urinalysis	02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Blood	Urinalysis	02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Nitrite	Urinalysis	02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Ph	Urinalysis	02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Protein	Urinalysis	02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/03/2011
BTNX Rapid Response Strep A Rapid Test Strips
K023270	Streptococcus, Group A	Bacteriology	02/02/2011
hema screen ER
K102664	Fecal Occult Blood	General Chemistry	02/02/2011
Independent Medical Co-Op, Inc., IMCO Pregnancy Test
K050741	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/02/2011
Medi-Weightloss Franchising USA, LLC. Medi-Weightloss Clinics Ketone Test Strips
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	02/02/2011
Express Diagnostics Internationl, Inc. One-Step EARLY PREGNANCY TEST (hCG URINE/SERUM COMBO)
K964461	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/24/2011
Great Lakes Medical Trading Accurate Diagnostics Pregnancy Test
K050741	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/24/2011
JANT Pharmacal Corp. Accustrip Value+ hCG Serum/Urine Pregnancy Test Strip
K974060	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/24/2011
JANT Pharmacal Corp. Accutest Value+ hCG Urine Pregnancy Test Device
K050741	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/24/2011
SA Scientific SAS Pregnancy Ultimate
K990684	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/21/2011
SA Scientific SAS Ultimate hCG
K990684	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/21/2011
Temcare Medical Design & Manufacturing, Inc. Solstice TB 100 Blood Glucose Monitoring System
K073492	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/21/2011
SCI International Inc, New Choice Ovulation Predictor (Cassette)
X100049	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	01/18/2011
SCI International Inc, New Choice Ovulation Predictor (Midstream)
X100049	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	01/18/2011
BTNX, Inc. Rapid Response Influenza A Test Cassette
K041441	Influenza A	Virology	01/10/2011
BTNX, Inc. Rapid Response Influenza B Test Cassette
K041439	Influenza B	Virology	01/10/2011
BTNX Inc. Rapid Response RSV Test
K022845	Respiratory Syncytial Virus	Virology	01/03/2011
Jant Pharmacal Accutest Value+ Pregnancy Combo Test (Cassette)
K984077	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/29/2010
Saless Enterprises Inc, New Choice Ovulation Predictor (Cassette)
X100053	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	12/29/2010
Saless Enterprises Inc, New Choice Ovulation Predictor (Midstream)
X100053	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	12/29/2010
Stanbio Laboratories, Stanbio alpha One-Step Pregnancy Combo Test (Cassette)
K984077	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/29/2010
Advantage Pro by NDC Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Ketone	Urinalysis	12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Bilirubin	Urinalysis	12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Blood	Urinalysis	12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Glucose	Urinalysis	12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Leukocytes	Urinalysis	12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Nitrite	Urinalysis	12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Ph	Urinalysis	12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Protein	Urinalysis	12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Urobilinogen	Urinalysis	12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Specific Gravity	Urinalysis	12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Ketone	Urinalysis	12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Bilirubin	Urinalysis	12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Blood	Urinalysis	12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Glucose	Urinalysis	12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Leukocytes	Urinalysis	12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Nitrite	Urinalysis	12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Ph	Urinalysis	12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Protein	Urinalysis	12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Urobilinogen	Urinalysis	12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips
K970250	Urine Qualitative Dipstick Specific Gravity	Urinalysis	12/21/2010
Acceava Strep A Test
K023766	Streptococcus, Group A	Bacteriology	12/17/2010
Siemens Hematest Reagent Tablets  (Pre-amendment device)
X100047	Fecal Occult Blood	General Chemistry	12/17/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Blood	Urinalysis	12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Ph	Urinalysis	12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Protein	Urinalysis	12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Bilirubin	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Blood	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Ph	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Protein	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Urobilinogen	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (2 parameters)
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (2 parameters)
K993850	Urine Qualitative Dipstick Protein	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (4 parameters)
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (4 parameters)
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (4 parameters)
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	12/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (4 parameters)
K993850	Urine Qualitative Dipstick Protein	Urinalysis	12/03/2010
EPS Bio Technology Corp. EasyMax L Self-Monitoring Blood Glucose System
K101457	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/22/2010
Centralcheck iFOBT Complete Fecal Occult Blood Test
K063693	Fecal Occult Blood	General Chemistry	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Glucose & Protein Urinalysis Reagent Strips (2 Parameters)
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Glucose & Protein Urinalysis Reagent Strips (2 Parameters)
K993850	Urine Qualitative Dipstick Protein	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Glucose, Protein, Nitrite & Leukocytes Urinalysis Reagent Strips (4 Parameters)
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Glucose, Protein, Nitrite & Leukocytes Urinalysis Reagent Strips (4 Parameters)
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Glucose, Protein, Nitrite & Leukocytes Urinalysis Reagent Strips (4 Parameters)
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Glucose, Protein, Nitrite & Leukocytes Urinalysis Reagent Strips (4 Parameters)
K993850	Urine Qualitative Dipstick Protein	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters)
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters)
K993850	Urine Qualitative Dipstick Bilirubin	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters)
K993850	Urine Qualitative Dipstick Blood	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters)
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters)
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters)
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters)
K993850	Urine Qualitative Dipstick Ph	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters)
K993850	Urine Qualitative Dipstick Protein	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters)
K993850	Urine Qualitative Dipstick Urobilinogen	Urinalysis	11/16/2010
Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters)
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	11/16/2010
SCI International Inc. Baby Test Pregnancy Test (For Home Use) (Cassette)
K023638	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/16/2010
SCI International Inc. U-Check Pregnancy Test (For Home Use) (Cassette)
K023638	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/16/2010
Cole Taylor Marketing, Inc. CTMI Combo Pregnancy
K981165	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/18/2010
Saless Enterprises Inc. Baby Test Preagnancy Test (For Home Use) (Cassette)
K023638	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/18/2010
Saless Enterprises Inc. New Choice Pregnancy Test (For Home Use) (Cassette)
K023638	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/18/2010
Saless Enterprises Inc. U-Check Pregnancy Test (For Home Use) (Cassette(
K023638	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Amphetamines	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Cannabinoids (THC)	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Phencyclidine (PCP)	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Cocaine Metabolites	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Opiates	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Methadone	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Methamphetamines	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Benzodiazepines	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Barbiturates	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Morphine	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Tricyclic Antidepressants	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Drug Screening Test Cards
K091588	Oxycodone	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Amphetamines	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Cannabinoids (THC)	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Phencyclidine (PCP)	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Cocaine Metabolites	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Opiates	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Methadone	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Methamphetamines	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Benzodiazepines	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Barbiturates	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Morphine	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Tricyclic Antidepressants	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	10/18/2010
UCP Biosciences, Inc. Multiple Drug Screen Cups
K091588	Oxycodone	Toxicology / TDM	10/18/2010
SCI International Inc. New Choice Pregnancy Test
K023638	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/07/2010
Accutest H. pylori Rapid Test-Serum (Dip Strip) {Jant Pharmacal}
K024360	Helicobacter Pylori	Bacteriology	10/04/2010
American IVD Biotechnology Services Inc. FOB/CRC Advanced+
K100031	Fecal Occult Blood	General Chemistry	10/04/2010
BTNX Inc. Rapid Response Fecal Immunochemical Test (FIT)
K100031	Fecal Occult Blood	General Chemistry	10/04/2010
BTNX, Inc. Strep A Rapid Test
K023270	Streptococcus, Group A	Bacteriology	10/04/2010
Consult Diagnostics Mononucleosis Cassette  (Whole Blood)
K961024	Infectious Mononucleosis Antibodies (Mono)	General Immunology	10/04/2010
Jant Pharmacal Accutest VALUE+ Pregnancy Urine Test  (Cassette)
K984076	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/04/2010
NexScreen LLC, NexScreen Cup
K082898	Amphetamines	Toxicology / TDM	10/04/2010
NexScreen LLC, NexScreen Cup
K082898	Cannabinoids (THC)	Toxicology / TDM	10/04/2010
NexScreen LLC, NexScreen Cup
K082898	Phencyclidine (PCP)	Toxicology / TDM	10/04/2010
NexScreen LLC, NexScreen Cup
K082898	Cocaine Metabolites	Toxicology / TDM	10/04/2010
NexScreen LLC, NexScreen Cup
K082898	Opiates	Toxicology / TDM	10/04/2010
NexScreen LLC, NexScreen Cup
K082898	Methadone	Toxicology / TDM	10/04/2010
NexScreen LLC, NexScreen Cup
K082898	Methamphetamines	Toxicology / TDM	10/04/2010
NexScreen LLC, NexScreen Cup
K082898	Benzodiazepines	Toxicology / TDM	10/04/2010
NexScreen LLC, NexScreen Cup
K082898	Barbiturates	Toxicology / TDM	10/04/2010
NexScreen LLC, NexScreen Cup
K082898	Tricyclic Antidepressants	Toxicology / TDM	10/04/2010
NexScreen LLC, NexScreen Cup
K082898	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	10/04/2010
NexScreen LLC, NexScreen Cup
K082898	Oxycodone	Toxicology / TDM	10/04/2010
Siemens Labstix Reagent Strips
K992257	Urine Qualitative Dipstick Ketone	Urinalysis	10/04/2010
Siemens Labstix Reagent Strips
K992257	Urine Qualitative Dipstick Blood	Urinalysis	10/04/2010
Siemens Labstix Reagent Strips
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	10/04/2010
Siemens Labstix Reagent Strips
K992257	Urine Qualitative Dipstick Ph	Urinalysis	10/04/2010
Siemens Labstix Reagent Strips
K992257	Urine Qualitative Dipstick Protein	Urinalysis	10/04/2010
Stanbio Laboratory, Stanbio alpha One-Step Pregnancy Urine Test  (Cassette)
K984076	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/04/2010
Tyson Bioresearch, Inc. EZ-Smart Plus Blood Glucose Monitoring System
K052818	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/04/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	09/14/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	09/14/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	09/14/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	09/14/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	09/14/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	09/14/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	09/14/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	09/14/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	09/14/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	09/14/2010
Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	09/14/2010
CTMI Strep A Rapid Test Strip {Cole Taylor Marketing Inc. Strep A}
K010582	Streptococcus, Group A	Bacteriology	09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup
K082898	Amphetamines	Toxicology / TDM	09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup
K082898	Cannabinoids (THC)	Toxicology / TDM	09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup
K082898	Phencyclidine (PCP)	Toxicology / TDM	09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup
K082898	Cocaine Metabolites	Toxicology / TDM	09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup
K082898	Opiates	Toxicology / TDM	09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup
K082898	Methadone	Toxicology / TDM	09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup
K082898	Methamphetamines	Toxicology / TDM	09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup
K082898	Benzodiazepines	Toxicology / TDM	09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup
K082898	Barbiturates	Toxicology / TDM	09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup
K082898	Tricyclic Antidepressants	Toxicology / TDM	09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup
K082898	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	09/14/2010
Jant Pharmacal Corporation ACCUTEST Drug Test Cup
K082898	Oxycodone	Toxicology / TDM	09/14/2010
Amedica Biotech AmediCheck Instant Test Cup
K082898	Amphetamines	Toxicology / TDM	09/08/2010
Amedica Biotech AmediCheck Instant Test Cup
K082898	Cannabinoids (THC)	Toxicology / TDM	09/08/2010
Amedica Biotech AmediCheck Instant Test Cup
K082898	Phencyclidine (PCP)	Toxicology / TDM	09/08/2010
Amedica Biotech AmediCheck Instant Test Cup
K082898	Cocaine Metabolites	Toxicology / TDM	09/08/2010
Amedica Biotech AmediCheck Instant Test Cup
K082898	Opiates	Toxicology / TDM	09/08/2010
Amedica Biotech AmediCheck Instant Test Cup
K082898	Methadone	Toxicology / TDM	09/08/2010
Amedica Biotech AmediCheck Instant Test Cup
K082898	Methamphetamines	Toxicology / TDM	09/08/2010
Amedica Biotech AmediCheck Instant Test Cup
K082898	Benzodiazepines	Toxicology / TDM	09/08/2010
Amedica Biotech AmediCheck Instant Test Cup
K082898	Barbiturates	Toxicology / TDM	09/08/2010
Amedica Biotech AmediCheck Instant Test Cup
K082898	Tricyclic Antidepressants	Toxicology / TDM	09/08/2010
Amedica Biotech AmediCheck Instant Test Cup
K082898	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	09/08/2010
Amedica Biotech AmediCheck Instant Test Cup
K082898	Oxycodone	Toxicology / TDM	09/08/2010
McKesson Medi-Lab Performance 10SG Urine Reagent Strips
K970250	Urine Qualitative Dipstick Ketone	Urinalysis	09/08/2010
McKesson Medi-Lab Performance 10SG Urine Reagent Strips
K970250	Urine Qualitative Dipstick Bilirubin	Urinalysis	09/08/2010
McKesson Medi-Lab Performance 10SG Urine Reagent Strips
K970250	Urine Qualitative Dipstick Blood	Urinalysis	09/08/2010
McKesson Medi-Lab Performance 10SG Urine Reagent Strips
K970250	Urine Qualitative Dipstick Glucose	Urinalysis	09/08/2010
McKesson Medi-Lab Performance 10SG Urine Reagent Strips
K970250	Urine Qualitative Dipstick Leukocytes	Urinalysis	09/08/2010
McKesson Medi-Lab Performance 10SG Urine Reagent Strips
K970250	Urine Qualitative Dipstick Nitrite	Urinalysis	09/08/2010
McKesson Medi-Lab Performance 10SG Urine Reagent Strips
K970250	Urine Qualitative Dipstick Ph	Urinalysis	09/08/2010
McKesson Medi-Lab Performance 10SG Urine Reagent Strips
K970250	Urine Qualitative Dipstick Protein	Urinalysis	09/08/2010
McKesson Medi-Lab Performance 10SG Urine Reagent Strips
K970250	Urine Qualitative Dipstick Urobilinogen	Urinalysis	09/08/2010
McKesson Medi-Lab Performance 10SG Urine Reagent Strips
K970250	Urine Qualitative Dipstick Specific Gravity	Urinalysis	09/08/2010
Siemens ICTOTEST Reagent Tablets  (urine, qualitative bilirubin)
X100013	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	09/08/2010
Bionime Corporation, Rightest GM250 Blood Glucose Monitoring System
K092052	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/01/2010
Bionime Corporation, Rightest GM260 Blood Glucose Monitoring System
K092052	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/01/2010
i-Sens Inc. DirecTest Blood Glucose Monitoring System
K083468	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/01/2010
Quidel RapidVue hCG test -Urine
K102175	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/01/2010
PSS Consult Diagnostics Strep A Dipstick
K023766	Streptococcus, Group A	Bacteriology	08/19/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Amphetamines	Toxicology / TDM	08/18/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Cannabinoids (THC)	Toxicology / TDM	08/18/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Phencyclidine (PCP)	Toxicology / TDM	08/18/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Cocaine Metabolites	Toxicology / TDM	08/18/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Opiates	Toxicology / TDM	08/18/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Methadone	Toxicology / TDM	08/18/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Methamphetamines	Toxicology / TDM	08/18/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Benzodiazepines	Toxicology / TDM	08/18/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Barbiturates	Toxicology / TDM	08/18/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Morphine	Toxicology / TDM	08/18/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Tricyclic Antidepressants	Toxicology / TDM	08/18/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	08/18/2010
American Screening Corporation Reveal Multi-Drug Testing Cups
K091588	Oxycodone	Toxicology / TDM	08/18/2010
Apex BioTechnology Corp. AutoSure Voice II Blood Glucose Monitoring System
K102037	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/18/2010
PSS Consult Diagnostics Strep A Dipstick
K010582	Streptococcus, Group A	Bacteriology	08/18/2010
Taidoc Technology Corporation ECHO TD-3227 Dual Blood Pressure/Blood Glucose Monitoring System
K092875	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/18/2010
TeenSaver Diagnostics, Inc TeenSavers Home Drug Test
K082898	Amphetamines	Toxicology / TDM	08/18/2010
TeenSaver Diagnostics, Inc TeenSavers Home Drug Test
K082898	Cannabinoids (THC)	Toxicology / TDM	08/18/2010
TeenSaver Diagnostics, Inc TeenSavers Home Drug Test
K082898	Phencyclidine (PCP)	Toxicology / TDM	08/18/2010
TeenSaver Diagnostics, Inc TeenSavers Home Drug Test
K082898	Cocaine Metabolites	Toxicology / TDM	08/18/2010
TeenSaver Diagnostics, Inc TeenSavers Home Drug Test
K082898	Opiates	Toxicology / TDM	08/18/2010
TeenSaver Diagnostics, Inc TeenSavers Home Drug Test
K082898	Methadone	Toxicology / TDM	08/18/2010
TeenSaver Diagnostics, Inc TeenSavers Home Drug Test
K082898	Methamphetamines	Toxicology / TDM	08/18/2010
TeenSaver Diagnostics, Inc TeenSavers Home Drug Test
K082898	Benzodiazepines	Toxicology / TDM	08/18/2010
TeenSaver Diagnostics, Inc TeenSavers Home Drug Test
K082898	Barbiturates	Toxicology / TDM	08/18/2010
TeenSaver Diagnostics, Inc TeenSavers Home Drug Test
K082898	Tricyclic Antidepressants	Toxicology / TDM	08/18/2010
TeenSaver Diagnostics, Inc TeenSavers Home Drug Test
K082898	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	08/18/2010
TeenSaver Diagnostics, Inc TeenSavers Home Drug Test
K082898	Oxycodone	Toxicology / TDM	08/18/2010
OMNIS Health Voice Blood Glucose Monitoring System
K073137	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/09/2010
IND Diagnostic, Inc. One Step Fecal Occult Blood Test
K100031	Fecal Occult Blood	General Chemistry	07/28/2010
Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cassette Test
K100051	Morphine	Toxicology / TDM	07/19/2010
Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cassette Test
K100051	Oxycodone	Toxicology / TDM	07/19/2010
Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cup Test
K100051	Morphine	Toxicology / TDM	07/19/2010
Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cup Test
K100051	Oxycodone	Toxicology / TDM	07/19/2010
Andon Medical Co., Ltd. AG-608 Blood Glucose Monitoring System
K093262	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/19/2010
Andon Medical Co., Ltd. AG-610 Blood Glucose Monitoring System
K093262	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/19/2010
Fora Care Inc. FORA G30a Blood Glucose Monitoring System
K100732	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/19/2010
Fora Care Inc. FORA G90 Perform Blood Glucose Monitoring System
K100405	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/19/2010
Consult Diagnostics Immunochemical Fecal Occult Blood Test (iFOBT)
K060463	Fecal Occult Blood	General Chemistry	07/08/2010
EPS Bio Technology Corp. EasyPlus mini R9N Self Monitoring Blood Glucose System
K101457	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/08/2010
Princeton BioMeditech BioSign Immunochemical Fecal Occult Blood Test (iFOBT)
K100817	Fecal Occult Blood	General Chemistry	07/08/2010
ProAdvantage by NDC Fecal Occult Blood Test Device
K902360	Fecal Occult Blood	General Chemistry	07/08/2010
Insight Medical Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	07/04/2010
Insight Medical Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	07/04/2010
Insight Medical Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	07/04/2010
Insight Medical Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	07/04/2010
Insight Medical Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	07/04/2010
Insight Medical Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	07/04/2010
Insight Medical Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	07/04/2010
Insight Medical Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	07/04/2010
Insight Medical Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	07/04/2010
Insight Medical Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	07/04/2010
Insight Medical Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/04/2010
Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	07/04/2010
Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	07/04/2010
Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	07/04/2010
Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	07/04/2010
Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	07/04/2010
Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	07/04/2010
Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	07/04/2010
Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	07/04/2010
Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	07/04/2010
Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	07/04/2010
Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/04/2010
Millenium Laboratories Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	07/04/2010
Millenium Laboratories Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	07/04/2010
Millenium Laboratories Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	07/04/2010
Millenium Laboratories Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	07/04/2010
Millenium Laboratories Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	07/04/2010
Millenium Laboratories Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	07/04/2010
Millenium Laboratories Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	07/04/2010
Millenium Laboratories Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	07/04/2010
Millenium Laboratories Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	07/04/2010
Millenium Laboratories Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	07/04/2010
Millenium Laboratories Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/04/2010
On the Spot Drug Testing Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	07/04/2010
On the Spot Drug Testing Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	07/04/2010
On the Spot Drug Testing Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	07/04/2010
On the Spot Drug Testing Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	07/04/2010
On the Spot Drug Testing Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	07/04/2010
On the Spot Drug Testing Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	07/04/2010
On the Spot Drug Testing Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	07/04/2010
On the Spot Drug Testing Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	07/04/2010
On the Spot Drug Testing Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	07/04/2010
On the Spot Drug Testing Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	07/04/2010
On the Spot Drug Testing Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	07/04/2010
Physicians' Test Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/04/2010
QuikTest USA, Inc. Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	07/04/2010
QuikTest USA, Inc. Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	07/04/2010
QuikTest USA, Inc. Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	07/04/2010
QuikTest USA, Inc. Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	07/04/2010
QuikTest USA, Inc. Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	07/04/2010
QuikTest USA, Inc. Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	07/04/2010
QuikTest USA, Inc. Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	07/04/2010
QuikTest USA, Inc. Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	07/04/2010
QuikTest USA, Inc. Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	07/04/2010
QuikTest USA, Inc. Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	07/04/2010
QuikTest USA, Inc. Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/04/2010
Screen Tox Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	07/04/2010
Screen Tox Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	07/04/2010
Screen Tox Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	07/04/2010
Screen Tox Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	07/04/2010
Screen Tox Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	07/04/2010
Screen Tox Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	07/04/2010
Screen Tox Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	07/04/2010
Screen Tox Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	07/04/2010
Screen Tox Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	07/04/2010
Screen Tox Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	07/04/2010
Screen Tox Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/04/2010
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	07/04/2010
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	07/04/2010
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	07/04/2010
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	07/04/2010
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	07/04/2010
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	07/04/2010
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	07/04/2010
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	07/04/2010
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	07/04/2010
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	07/04/2010
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/04/2010
Tyson Bioresearch, Inc. TysonBio CONTROL Blood Glucose Monitoring System
K052818	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/04/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Amphetamines	Toxicology / TDM	07/01/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Cannabinoids (THC)	Toxicology / TDM	07/01/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Phencyclidine (PCP)	Toxicology / TDM	07/01/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Cocaine Metabolites	Toxicology / TDM	07/01/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Opiates	Toxicology / TDM	07/01/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Methadone	Toxicology / TDM	07/01/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Methamphetamines	Toxicology / TDM	07/01/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Benzodiazepines	Toxicology / TDM	07/01/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Barbiturates	Toxicology / TDM	07/01/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Tricyclic Antidepressants	Toxicology / TDM	07/01/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/01/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Oxycodone	Toxicology / TDM	07/01/2010
sanofi aventis BGStar Blood Glucose Monitoring System
K072413	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/27/2010
Allmedicus AGM-4000 GlucoDr Auto Blood Glucose Monitoring System
K083628	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/24/2010
Bionime USA Corporation Rightest Blood Glucose Monitoring System, Model GM550
K092052	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/24/2010
GenExel-Sein, Inc., DUO-CARE Blood Glucose and Blood Pressure Monitoring System
K080853	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/24/2010
Abbott FreeStyle 3 Blood Glucose Monitoring System
K092638	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/18/2010
Abbott FreeStyle 5 Blood Glucose Monitoring System
K092638	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/18/2010
Abbott FreeStyle Flash Blood Glucose Monitoring System
K092638	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/18/2010
Abbott FreeStyle Freedom Blood Glucose Monitoring System
K092638	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/18/2010
Biotron Diagnostics inc., Dr. G Glucose Meter Glucose Monitoring System
K052818	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/18/2010
Siemens MULTISTIX PRO 10LS
K992257	Urine Qualitative Dipstick Ketone	Urinalysis	06/18/2010
Siemens MULTISTIX PRO 10LS
K992257	Urine Qualitative Dipstick Blood	Urinalysis	06/18/2010
Siemens MULTISTIX PRO 10LS
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	06/18/2010
Siemens MULTISTIX PRO 10LS
K992257	Urine Qualitative Dipstick Leukocytes	Urinalysis	06/18/2010
Siemens MULTISTIX PRO 10LS
K992257	Urine Qualitative Dipstick Nitrite	Urinalysis	06/18/2010
Siemens MULTISTIX PRO 10LS
K992257	Urine Qualitative Dipstick Ph	Urinalysis	06/18/2010
Siemens MULTISTIX PRO 10LS
K992257	Urine Qualitative Dipstick Protein	Urinalysis	06/18/2010
Siemens MULTISTIX PRO 10LS
K992257	Urine Qualitative Dipstick Specific Gravity	Urinalysis	06/18/2010
Siemens MULTISTIX PRO 10LS
K992257	Urine Qualitative Dipstick Creatinine	Urinalysis	06/18/2010
Siemens MULTISTIX Pro 11
K992257	Urine Qualitative Dipstick Ketone	Urinalysis	06/18/2010
Siemens MULTISTIX Pro 11
K992257	Urine Qualitative Dipstick Bilirubin	Urinalysis	06/18/2010
Siemens MULTISTIX Pro 11
K992257	Urine Qualitative Dipstick Blood	Urinalysis	06/18/2010
Siemens MULTISTIX Pro 11
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	06/18/2010
Siemens MULTISTIX Pro 11
K992257	Urine Qualitative Dipstick Leukocytes	Urinalysis	06/18/2010
Siemens MULTISTIX Pro 11
K992257	Urine Qualitative Dipstick Nitrite	Urinalysis	06/18/2010
Siemens MULTISTIX Pro 11
K992257	Urine Qualitative Dipstick Ph	Urinalysis	06/18/2010
Siemens MULTISTIX Pro 11
K992257	Urine Qualitative Dipstick Specific Gravity	Urinalysis	06/18/2010
Siemens MULTISTIX Pro 11
K992257	Urine Qualitative Dipstick Creatinine	Urinalysis	06/18/2010
Siemens MULTISTIX Pro 11
K992257	Urinary Protein, Qualitative	Urinalysis	06/18/2010
Standard Diagnostics USA SmartLink GOLD Blood Glucose Monitoring System
K100398	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/18/2010
Saless Enterprises, Inc. New Choice Urinary Tract Infection Test Strips
K063295	Nitrite, Urine	General Chemistry	06/14/2010
Saless Enterprises, Inc. New Choice Urinary Tract Infection Test Strips
K063295	Leukocyte Esterase, Urinary	Urinalysis	06/14/2010
Express Diagnostic International, Inc. Urine Pregnancy Cassette Test
K936031	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/04/2010
Express Diagnostic International, Inc. Urine Pregnancy Dipstick Test
K964536	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/04/2010
Aventir Biotech ForSure Urine Reagent Strips
K051727	Urine Qualitative Dipstick Ketone	Urinalysis	06/03/2010
Aventir Biotech ForSure Urine Reagent Strips
K051727	Urine Qualitative Dipstick Bilirubin	Urinalysis	06/03/2010
Aventir Biotech ForSure Urine Reagent Strips
K051727	Urine Qualitative Dipstick Blood	Urinalysis	06/03/2010
Aventir Biotech ForSure Urine Reagent Strips
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	06/03/2010
Aventir Biotech ForSure Urine Reagent Strips
K051727	Urine Qualitative Dipstick Leukocytes	Urinalysis	06/03/2010
Aventir Biotech ForSure Urine Reagent Strips
K051727	Urine Qualitative Dipstick Nitrite	Urinalysis	06/03/2010
Aventir Biotech ForSure Urine Reagent Strips
K051727	Urine Qualitative Dipstick Protein	Urinalysis	06/03/2010
Aventir Biotech ForSure Urine Reagent Strips
K051727	Urine Qualitative Dipstick Urobilinogen	Urinalysis	06/03/2010
Aventir Biotech ForSure Urine Reagent Strips
K051727	Urine Qualitative Dipstick Specific Gravity	Urinalysis	06/03/2010
Aventir Biotech ForSure Urine Reagent Strips
K051727	pH, Urine	General Chemistry	06/03/2010
Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer
K070929	Urine Qualitative Dipstick Ketone	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer
K070929	Urine Qualitative Dipstick Bilirubin	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer
K070929	Urine Qualitative Dipstick Blood	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer
K070929	Urine Qualitative Dipstick Glucose	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer
K070929	Urine Qualitative Dipstick Leukocytes	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer
K070929	Urine Qualitative Dipstick Nitrite	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer
K070929	Urine Qualitative Dipstick Ph	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer
K070929	Urine Qualitative Dipstick Protein	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer
K070929	Urine Qualitative Dipstick Urobilinogen	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer
K070929	Urine Qualitative Dipstick Specific Gravity	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips
K061559	Urine Qualitative Dipstick Blood	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips
K061559	Urine Qualitative Dipstick Ph	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips
K061559	Urine Qualitative Dipstick Protein	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	06/03/2010
Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips Urine Reagent Strips
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	06/03/2010
Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	06/03/2010
Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	06/03/2010
Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips
K061559	Urine Qualitative Dipstick Blood	Urinalysis	06/03/2010
Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	06/03/2010
Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	06/03/2010
Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	06/03/2010
Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips
K061559	Urine Qualitative Dipstick Ph	Urinalysis	06/03/2010
Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips
K061559	Urine Qualitative Dipstick Protein	Urinalysis	06/03/2010
Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	06/03/2010
Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	06/03/2010
HealthPia USA LLC, GlucoPhone Blood Glucose Monitoring System
K091168	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	06/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	06/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips
K061559	Urine Qualitative Dipstick Blood	Urinalysis	06/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	06/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	06/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	06/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips
K061559	Urine Qualitative Dipstick Ph	Urinalysis	06/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips
K061559	Urine Qualitative Dipstick Protein	Urinalysis	06/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	06/03/2010
Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	06/03/2010
Liberty Medical, Liberty Next Generation Blood Glucose Monitoring System
K073573	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Amphetamines	Toxicology / TDM	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Cannabinoids (THC)	Toxicology / TDM	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Phencyclidine (PCP)	Toxicology / TDM	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Cocaine Metabolites	Toxicology / TDM	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Opiates	Toxicology / TDM	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Methadone	Toxicology / TDM	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Methamphetamines	Toxicology / TDM	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Benzodiazepines	Toxicology / TDM	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Barbiturates	Toxicology / TDM	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Morphine	Toxicology / TDM	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Tricyclic Antidepressants	Toxicology / TDM	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	06/03/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Oxycodone	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Amphetamines	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Cannabinoids (THC)	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Phencyclidine (PCP)	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Cocaine Metabolites	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Opiates	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Methadone	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Methamphetamines	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Benzodiazepines	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Barbiturates	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Morphine	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Tricyclic Antidepressants	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Oxycodone	Toxicology / TDM	06/03/2010
Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strip
K051727	pH, Urine	General Chemistry	06/03/2010
Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips
K051727	Urine Qualitative Dipstick Ketone	Urinalysis	06/03/2010
Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips
K051727	Urine Qualitative Dipstick Bilirubin	Urinalysis	06/03/2010
Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips
K051727	Urine Qualitative Dipstick Blood	Urinalysis	06/03/2010
Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	06/03/2010
Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips
K051727	Urine Qualitative Dipstick Leukocytes	Urinalysis	06/03/2010
Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips
K051727	Urine Qualitative Dipstick Nitrite	Urinalysis	06/03/2010
Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips
K051727	Urine Qualitative Dipstick Protein	Urinalysis	06/03/2010
Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips
K051727	Urine Qualitative Dipstick Urobilinogen	Urinalysis	06/03/2010
Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips
K051727	Urine Qualitative Dipstick Specific Gravity	Urinalysis	06/03/2010
Target, up& up Blood Glucose meter Monitoring System
K073573	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/03/2010
Immunostics, Inc., hema-screen STAT
K905782	Fecal Occult Blood	General Chemistry	05/20/2010
SpermCheck Fertility
K100341	Semen	Hematology	05/20/2010
Fora Care Inc. FORA V20 Blood Glucose Monitoring System
K100406	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/13/2010
Home Aide Diagnostics, Inc., Easy Talk Talking Blood Glucose Monitoring System
K100560	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/13/2010
Omnis Health Victory Blood Glucose Monitoring System
K083628	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/13/2010
Tyson Bioresearch, Inc., TysonBio Evolve Blood Glucose Monitoring System
K073492	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/13/2010
Tyson Bioresearch, Inc., TysonBio TB100 Blood Glucose Monitoring System
K073492	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/13/2010
Fora Care Inc. Fora G31a /TD-4256A Blood Glucose Monitoring System
K094005	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/10/2010
Fora Care Inc. Fora G31b /TD-4256B Blood Glucose Monitoring System
K094005	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/10/2010
Siemens MULTISTIX 10 SG Reagent Strips
K992257	Urine Qualitative Dipstick Ketone	Urinalysis	05/10/2010
Siemens MULTISTIX 10 SG Reagent Strips
K992257	Urine Qualitative Dipstick Bilirubin	Urinalysis	05/10/2010
Siemens MULTISTIX 10 SG Reagent Strips
K992257	Urine Qualitative Dipstick Blood	Urinalysis	05/10/2010
Siemens MULTISTIX 10 SG Reagent Strips
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	05/10/2010
Siemens MULTISTIX 10 SG Reagent Strips
K992257	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/10/2010
Siemens MULTISTIX 10 SG Reagent Strips
K992257	Urine Qualitative Dipstick Nitrite	Urinalysis	05/10/2010
Siemens MULTISTIX 10 SG Reagent Strips
K992257	Urine Qualitative Dipstick Ph	Urinalysis	05/10/2010
Siemens MULTISTIX 10 SG Reagent Strips
K992257	Urine Qualitative Dipstick Protein	Urinalysis	05/10/2010
Siemens MULTISTIX 10 SG Reagent Strips
K992257	Urine Qualitative Dipstick Urobilinogen	Urinalysis	05/10/2010
Siemens MULTISTIX 10 SG Reagent Strips
K992257	Urine Qualitative Dipstick Specific Gravity	Urinalysis	05/10/2010
Siemens MULTISTIX 5 Reagent Strips
K992257	Urine Qualitative Dipstick Blood	Urinalysis	05/10/2010
Siemens MULTISTIX 5 Reagent Strips
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	05/10/2010
Siemens MULTISTIX 5 Reagent Strips
K992257	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/10/2010
Siemens MULTISTIX 5 Reagent Strips
K992257	Urine Qualitative Dipstick Nitrite	Urinalysis	05/10/2010
Siemens MULTISTIX 5 Reagent Strips
K992257	Urine Qualitative Dipstick Protein	Urinalysis	05/10/2010
Siemens MULTISTIX 7 Reagent Strips
K992257	Urine Qualitative Dipstick Ketone	Urinalysis	05/10/2010
Siemens MULTISTIX 7 Reagent Strips
K992257	Urine Qualitative Dipstick Blood	Urinalysis	05/10/2010
Siemens MULTISTIX 7 Reagent Strips
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	05/10/2010
Siemens MULTISTIX 7 Reagent Strips
K992257	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/10/2010
Siemens MULTISTIX 7 Reagent Strips
K992257	Urine Qualitative Dipstick Nitrite	Urinalysis	05/10/2010
Siemens MULTISTIX 7 Reagent Strips
K992257	Urine Qualitative Dipstick Ph	Urinalysis	05/10/2010
Siemens MULTISTIX 7 Reagent Strips
K992257	Urine Qualitative Dipstick Protein	Urinalysis	05/10/2010
Siemens MULTISTIX 8 SG Reagent Strips
K992257	Urine Qualitative Dipstick Ketone	Urinalysis	05/10/2010
Siemens MULTISTIX 8 SG Reagent Strips
K992257	Urine Qualitative Dipstick Blood	Urinalysis	05/10/2010
Siemens MULTISTIX 8 SG Reagent Strips
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	05/10/2010
Siemens MULTISTIX 8 SG Reagent Strips
K992257	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/10/2010
Siemens MULTISTIX 8 SG Reagent Strips
K992257	Urine Qualitative Dipstick Nitrite	Urinalysis	05/10/2010
Siemens MULTISTIX 8 SG Reagent Strips
K992257	Urine Qualitative Dipstick Ph	Urinalysis	05/10/2010
Siemens MULTISTIX 8 SG Reagent Strips
K992257	Urine Qualitative Dipstick Protein	Urinalysis	05/10/2010
Siemens MULTISTIX 8 SG Reagent Strips
K992257	Urine Qualitative Dipstick Specific Gravity	Urinalysis	05/10/2010
Siemens MULTISTIX 9 Reagent Strips
K992257	Urine Qualitative Dipstick Ketone	Urinalysis	05/10/2010
Siemens MULTISTIX 9 Reagent Strips
K992257	Urine Qualitative Dipstick Bilirubin	Urinalysis	05/10/2010
Siemens MULTISTIX 9 Reagent Strips
K992257	Urine Qualitative Dipstick Blood	Urinalysis	05/10/2010
Siemens MULTISTIX 9 Reagent Strips
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	05/10/2010
Siemens MULTISTIX 9 Reagent Strips
K992257	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/10/2010
Siemens MULTISTIX 9 Reagent Strips
K992257	Urine Qualitative Dipstick Nitrite	Urinalysis	05/10/2010
Siemens MULTISTIX 9 Reagent Strips
K992257	Urine Qualitative Dipstick Ph	Urinalysis	05/10/2010
Siemens MULTISTIX 9 Reagent Strips
K992257	Urine Qualitative Dipstick Protein	Urinalysis	05/10/2010
Siemens MULTISTIX 9 Reagent Strips
K992257	Urine Qualitative Dipstick Urobilinogen	Urinalysis	05/10/2010
Siemens MULTISTIX 9 SG Reagent Strips
K992257	Urine Qualitative Dipstick Ketone	Urinalysis	05/10/2010
Siemens MULTISTIX 9 SG Reagent Strips
K992257	Urine Qualitative Dipstick Bilirubin	Urinalysis	05/10/2010
Siemens MULTISTIX 9 SG Reagent Strips
K992257	Urine Qualitative Dipstick Blood	Urinalysis	05/10/2010
Siemens MULTISTIX 9 SG Reagent Strips
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	05/10/2010
Siemens MULTISTIX 9 SG Reagent Strips
K992257	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/10/2010
Siemens MULTISTIX 9 SG Reagent Strips
K992257	Urine Qualitative Dipstick Nitrite	Urinalysis	05/10/2010
Siemens MULTISTIX 9 SG Reagent Strips
K992257	Urine Qualitative Dipstick Ph	Urinalysis	05/10/2010
Siemens MULTISTIX 9 SG Reagent Strips
K992257	Urine Qualitative Dipstick Protein	Urinalysis	05/10/2010
Siemens MULTISTIX 9 SG Reagent Strips
K992257	Urine Qualitative Dipstick Specific Gravity	Urinalysis	05/10/2010
Siemens MULTISTIX Reagent Strips
K992257	Urine Qualitative Dipstick Ketone	Urinalysis	05/10/2010
Siemens MULTISTIX Reagent Strips
K992257	Urine Qualitative Dipstick Blood	Urinalysis	05/10/2010
Siemens MULTISTIX Reagent Strips
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	05/10/2010
Siemens MULTISTIX Reagent Strips
K992257	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/10/2010
Siemens MULTISTIX Reagent Strips
K992257	Urine Qualitative Dipstick Ph	Urinalysis	05/10/2010
Siemens MULTISTIX Reagent Strips
K992257	Urine Qualitative Dipstick Protein	Urinalysis	05/10/2010
Siemens MULTISTIX Reagent Strips
K992257	Urine Qualitative Dipstick Urobilinogen	Urinalysis	05/10/2010
Siemens MULTISTIX Reagent Strips
K992257	Urine Qualitative Dipstick Specific Gravity	Urinalysis	05/10/2010
US Diagnostics ProScreen Drugs of Abuse Cup  (OTC)
K052115	Amphetamines	Toxicology / TDM	05/10/2010
US Diagnostics ProScreen Drugs of Abuse Cup  (OTC)
K052115	Cannabinoids (THC)	Toxicology / TDM	05/10/2010
US Diagnostics ProScreen Drugs of Abuse Cup  (OTC)
K052115	Phencyclidine (PCP)	Toxicology / TDM	05/10/2010
US Diagnostics ProScreen Drugs of Abuse Cup  (OTC)
K052115	Cocaine Metabolites	Toxicology / TDM	05/10/2010
US Diagnostics ProScreen Drugs of Abuse Cup  (OTC)
K052115	Opiates	Toxicology / TDM	05/10/2010
US Diagnostics ProScreen Drugs of Abuse Cup  (OTC)
K052115	Methadone	Toxicology / TDM	05/10/2010
US Diagnostics ProScreen Drugs of Abuse Cup  (OTC)
K052115	Methamphetamines	Toxicology / TDM	05/10/2010
US Diagnostics ProScreen Drugs of Abuse Cup  (OTC)
K052115	Benzodiazepines	Toxicology / TDM	05/10/2010
US Diagnostics ProScreen Drugs of Abuse Cup  (OTC)
K052115	Barbiturates	Toxicology / TDM	05/10/2010
US Diagnostics ProScreen Drugs of Abuse Cup  (OTC)
K052115	Tricyclic Antidepressants	Toxicology / TDM	05/10/2010
US Diagnostics ProScreen Drugs of Abuse Cup  (OTC)
K052115	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/10/2010
US Diagnostics ProScreen Drugs of Abuse Cup  (OTC)
K052115	Oxycodone	Toxicology / TDM	05/10/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Amphetamines	Toxicology / TDM	05/06/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Cannabinoids (THC)	Toxicology / TDM	05/06/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Phencyclidine (PCP)	Toxicology / TDM	05/06/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Cocaine Metabolites	Toxicology / TDM	05/06/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Opiates	Toxicology / TDM	05/06/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Methadone	Toxicology / TDM	05/06/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Methamphetamines	Toxicology / TDM	05/06/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Benzodiazepines	Toxicology / TDM	05/06/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Barbiturates	Toxicology / TDM	05/06/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Tricyclic Antidepressants	Toxicology / TDM	05/06/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/06/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Oxycodone	Toxicology / TDM	05/06/2010
Alliance International Co., Ltd., A-Check DS-A Blood Glucose Monitoring System
K082965	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/04/2010
Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	05/03/2010
Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	05/03/2010
Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	05/03/2010
Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	05/03/2010
Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	05/03/2010
Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	05/03/2010
Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	05/03/2010
Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	05/03/2010
Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	05/03/2010
Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	05/03/2010
Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/03/2010
Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	05/03/2010
Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	05/03/2010
Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	05/03/2010
Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	05/03/2010
Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	05/03/2010
Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	05/03/2010
Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	05/03/2010
Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	05/03/2010
Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	05/03/2010
Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	05/03/2010
Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/03/2010
Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	05/03/2010
Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	05/03/2010
Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	05/03/2010
Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	05/03/2010
Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	05/03/2010
Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	05/03/2010
Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	05/03/2010
Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	05/03/2010
Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	05/03/2010
Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	05/03/2010
Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/03/2010
Diabetic Supply of Suncoast, Inc., ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System
K093940	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Amphetamines	Toxicology / TDM	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Cannabinoids (THC)	Toxicology / TDM	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Phencyclidine (PCP)	Toxicology / TDM	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Cocaine Metabolites	Toxicology / TDM	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Opiates	Toxicology / TDM	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Methadone	Toxicology / TDM	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Methamphetamines	Toxicology / TDM	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Benzodiazepines	Toxicology / TDM	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Barbiturates	Toxicology / TDM	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Morphine	Toxicology / TDM	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Tricyclic Antidepressants	Toxicology / TDM	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	04/30/2010
Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups
K091588	Oxycodone	Toxicology / TDM	04/30/2010
BTNX Inc. Rapid Response LH Ovulation Test
X100002	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	04/21/2010
CLIAwaived, Inc. Rapid Drug Test Cup  (OTC)
K052115	Amphetamines	Toxicology / TDM	04/21/2010
CLIAwaived, Inc. Rapid Drug Test Cup  (OTC)
K052115	Cannabinoids (THC)	Toxicology / TDM	04/21/2010
CLIAwaived, Inc. Rapid Drug Test Cup  (OTC)
K052115	Phencyclidine (PCP)	Toxicology / TDM	04/21/2010
CLIAwaived, Inc. Rapid Drug Test Cup  (OTC)
K052115	Cocaine Metabolites	Toxicology / TDM	04/21/2010
CLIAwaived, Inc. Rapid Drug Test Cup  (OTC)
K052115	Opiates	Toxicology / TDM	04/21/2010
CLIAwaived, Inc. Rapid Drug Test Cup  (OTC)
K052115	Methadone	Toxicology / TDM	04/21/2010
CLIAwaived, Inc. Rapid Drug Test Cup  (OTC)
K052115	Methamphetamines	Toxicology / TDM	04/21/2010
CLIAwaived, Inc. Rapid Drug Test Cup  (OTC)
K052115	Benzodiazepines	Toxicology / TDM	04/21/2010
CLIAwaived, Inc. Rapid Drug Test Cup  (OTC)
K052115	Barbiturates	Toxicology / TDM	04/21/2010
CLIAwaived, Inc. Rapid Drug Test Cup  (OTC)
K052115	Tricyclic Antidepressants	Toxicology / TDM	04/21/2010
CLIAwaived, Inc. Rapid Drug Test Cup  (OTC)
K052115	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	04/21/2010
CLIAwaived, Inc. Rapid Drug Test Cup  (OTC)
K052115	Oxycodone	Toxicology / TDM	04/21/2010
Express Diagnostics, DRUGCHECK Waive Cup
K052115	Amphetamines	Toxicology / TDM	04/21/2010
Express Diagnostics, DRUGCHECK Waive Cup
K052115	Cannabinoids (THC)	Toxicology / TDM	04/21/2010
Express Diagnostics, DRUGCHECK Waive Cup
K052115	Phencyclidine (PCP)	Toxicology / TDM	04/21/2010
Express Diagnostics, DRUGCHECK Waive Cup
K052115	Cocaine Metabolites	Toxicology / TDM	04/21/2010
Express Diagnostics, DRUGCHECK Waive Cup
K052115	Opiates	Toxicology / TDM	04/21/2010
Express Diagnostics, DRUGCHECK Waive Cup
K052115	Methadone	Toxicology / TDM	04/21/2010
Express Diagnostics, DRUGCHECK Waive Cup
K052115	Methamphetamines	Toxicology / TDM	04/21/2010
Express Diagnostics, DRUGCHECK Waive Cup
K052115	Benzodiazepines	Toxicology / TDM	04/21/2010
Express Diagnostics, DRUGCHECK Waive Cup
K052115	Barbiturates	Toxicology / TDM	04/21/2010
Express Diagnostics, DRUGCHECK Waive Cup
K052115	Tricyclic Antidepressants	Toxicology / TDM	04/21/2010
Express Diagnostics, DRUGCHECK Waive Cup
K052115	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	04/21/2010
Express Diagnostics, DRUGCHECK Waive Cup
K052115	Oxycodone	Toxicology / TDM	04/21/2010
Fora Care Inc. U-Right TD-3252 Blood Glucose plus Blood Pressure Monitoring System
K091555	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/21/2010
Life Systems Inc. Odyssey Blood Glucose Monitoring System
K062799	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/21/2010
Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup
K052115	Amphetamines	Toxicology / TDM	04/21/2010
Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup
K052115	Cannabinoids (THC)	Toxicology / TDM	04/21/2010
Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup
K052115	Phencyclidine (PCP)	Toxicology / TDM	04/21/2010
Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup
K052115	Cocaine Metabolites	Toxicology / TDM	04/21/2010
Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup
K052115	Opiates	Toxicology / TDM	04/21/2010
Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup
K052115	Methadone	Toxicology / TDM	04/21/2010
Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup
K052115	Methamphetamines	Toxicology / TDM	04/21/2010
Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup
K052115	Benzodiazepines	Toxicology / TDM	04/21/2010
Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup
K052115	Barbiturates	Toxicology / TDM	04/21/2010
Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup
K052115	Tricyclic Antidepressants	Toxicology / TDM	04/21/2010
Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup
K052115	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	04/21/2010
Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup
K052115	Oxycodone	Toxicology / TDM	04/21/2010
Noble Medical Inc. NOBLE 1 Step Cup  (OTC)
K052115	Amphetamines	Toxicology / TDM	04/21/2010
Noble Medical Inc. NOBLE 1 Step Cup  (OTC)
K052115	Cannabinoids (THC)	Toxicology / TDM	04/21/2010
Noble Medical Inc. NOBLE 1 Step Cup  (OTC)
K052115	Phencyclidine (PCP)	Toxicology / TDM	04/21/2010
Noble Medical Inc. NOBLE 1 Step Cup  (OTC)
K052115	Cocaine Metabolites	Toxicology / TDM	04/21/2010
Noble Medical Inc. NOBLE 1 Step Cup  (OTC)
K052115	Opiates	Toxicology / TDM	04/21/2010
Noble Medical Inc. NOBLE 1 Step Cup  (OTC)
K052115	Methadone	Toxicology / TDM	04/21/2010
Noble Medical Inc. NOBLE 1 Step Cup  (OTC)
K052115	Methamphetamines	Toxicology / TDM	04/21/2010
Noble Medical Inc. NOBLE 1 Step Cup  (OTC)
K052115	Benzodiazepines	Toxicology / TDM	04/21/2010
Noble Medical Inc. NOBLE 1 Step Cup  (OTC)
K052115	Barbiturates	Toxicology / TDM	04/21/2010
Noble Medical Inc. NOBLE 1 Step Cup  (OTC)
K052115	Tricyclic Antidepressants	Toxicology / TDM	04/21/2010
Noble Medical Inc. NOBLE 1 Step Cup  (OTC)
K052115	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	04/21/2010
Noble Medical Inc. NOBLE 1 Step Cup  (OTC)
K052115	Oxycodone	Toxicology / TDM	04/21/2010
Redwood Toxicology Laboratory, Inc Reditest Freedom Cup
K052115	Amphetamines	Toxicology / TDM	04/21/2010
Redwood Toxicology Laboratory, Inc Reditest Freedom Cup
K052115	Cannabinoids (THC)	Toxicology / TDM	04/21/2010
Redwood Toxicology Laboratory, Inc Reditest Freedom Cup
K052115	Phencyclidine (PCP)	Toxicology / TDM	04/21/2010
Redwood Toxicology Laboratory, Inc Reditest Freedom Cup
K052115	Cocaine Metabolites	Toxicology / TDM	04/21/2010
Redwood Toxicology Laboratory, Inc Reditest Freedom Cup
K052115	Opiates	Toxicology / TDM	04/21/2010
Redwood Toxicology Laboratory, Inc Reditest Freedom Cup
K052115	Methadone	Toxicology / TDM	04/21/2010
Redwood Toxicology Laboratory, Inc Reditest Freedom Cup
K052115	Methamphetamines	Toxicology / TDM	04/21/2010
Redwood Toxicology Laboratory, Inc Reditest Freedom Cup
K052115	Benzodiazepines	Toxicology / TDM	04/21/2010
Redwood Toxicology Laboratory, Inc Reditest Freedom Cup
K052115	Barbiturates	Toxicology / TDM	04/21/2010
Redwood Toxicology Laboratory, Inc Reditest Freedom Cup
K052115	Tricyclic Antidepressants	Toxicology / TDM	04/21/2010
Redwood Toxicology Laboratory, Inc Reditest Freedom Cup
K052115	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	04/21/2010
Redwood Toxicology Laboratory, Inc Reditest Freedom Cup
K052115	Oxycodone	Toxicology / TDM	04/21/2010
CoaguSense Self-Test Prothrombin Time/INR Monitoring System {Prescription Home Use}
K093243	Prothrombin Time (PT)	Hematology	04/15/2010
Common Sense Ltd. VS-Sense Test  (Qualitative)
K091287	Vaginal pH	General Chemistry	04/15/2010
Fora Care Inc. FORA V30/TD-4242 Blood Glucose Monitoring System
K093635	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/15/2010
Fora Care U-Right TD-4238 Blood Glucose Monitoring System
K092902	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/15/2010
Fora Care U-Right TD-4246 Blood Glucose Monitoring System
K092902	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/15/2010
Hummingbird Medical, Inc., Oracle Blood Glucose Monitoring System
K091815	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/15/2010
Progressive Health Supply and Source Corporation, Smartest Persona Blood Glucose Monitoring System
K100701	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/15/2010
Simple Diagnostics CLEVER CHOICE Auto-code Pro Blood Glucose Monitoring System
K093506	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/15/2010
Gemco Medical EasyMax V Self-Monitoring Blood Glucose System
K092894	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/07/2010
McKesson Medi-Lab Performance Infectious Mononucleosis Test  (For whole blood)
K961024	Infectious Mononucleosis Antibodies (Mono)	General Immunology	03/31/2010
Simple Diagnostics CLEVER CHOICE mini Blood Glucose Monitoring System
K093941	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/31/2010
BioSense Medical, SoloV2 Audible Blood Glucose Management System
K093764	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/25/2010
Gluco Perfect, L.L.C., Perfect 3 Blood Glucose Monitoring System
K091815	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/09/2010
NDC Inc., Pro Advantage by NDC Urine Pregnancy Test Strip
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/09/2010
Roche Diagnostics CoaguChek XS Plus PST System
K092940	Prothrombin Time (PT)	Hematology	03/09/2010
BTNX, Inc Rapid Response Thyroid Stimulating Hormone (TSH) Test Cassette  (Whole Blood)
K990658	Thyroid Stimulating Hormone (TSH)	Endocrinology	03/04/2010
Home Diagnostics Grace IV Prestige IQ Blood Glucose Monitoring System
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/04/2010
Links Medical Products Inc. microdot Blood Glucose Monitoring System
K070524	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/04/2010
Aventir Biotech LLC, FORSURE TSH test  (Whole Blood)
K990658	Thyroid Stimulating Hormone (TSH)	Endocrinology	03/02/2010
Home Health UK, Ltd. One Step HCG Urine Pregnancy Test (Cassette Style)
K062703	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/02/2010
Home Health UK, Ltd. One Step HCG Urine Pregnancy Test (Midstream)
K062703	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/02/2010
Home Health UK, Ltd. One Step HCG Urine Pregnancy Test (Strip Style)
K062703	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/02/2010
Nova Biomedical Nova Max Plus Glucose and B-Ketone Monitoring System
K091547	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/02/2010
Nova Biomedical Nova Max Plus Glucose and B-Ketone Monitoring System
K091547	Ketone, Blood	General Chemistry	03/02/2010
Tyson Bioresearch Inc. TysonBio Superb Blood Glucose Monitoring System
K072854	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/02/2010
Tyson Bioresearch Inc. TysonBio Vigor Blood Glucose Monitoring System
K072854	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/02/2010
Diabetic Supply of Suncoast, Inc., Advocate Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, TD-3223E
K093592	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/01/2010
Fora Care Inc. Fora G70/TD-4273 Blood Glucose Monitoring System
K093005	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/01/2010
Fora Care Inc. Fora G71a / TD-4274 Blood Glucose Monitoring System
K093712	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/01/2010
Fora Care Inc. Fora G72/TD-4264 Blood Glucose Monitoring System
K093005	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/01/2010
Inverness Medical Clearview iFOBT Complete Fecal Occult Blood Test
K063693	Fecal Occult Blood	General Chemistry	03/01/2010
Standard Diagnostics USA SD Check Gold Blood Glucose Monitoring System
K082683	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/18/2010
OK Biotech Co., Ltd. OKmeter Match Blood Glucose Monitoring System
K090609	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/16/2010
Bayer Didget Blood Glucose Monitoring System
K090628	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/01/2010
Care Diagnostic Clarity IFOB Test
K052598	Fecal Occult Blood	General Chemistry	01/26/2010
Heritage House '76 Inc., The Precious Feet Midstream Pregnancy Test
K974059	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/26/2010
ARJ Pylo-Plus Urease Test {H. pylori detection}
K052708	Helicobacter Pylori	Bacteriology	01/20/2010
CTL Scientific Supply Corp. eBcarryon Blood Glucose Monitoring System
K091765	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/20/2010
Progressive Health Supply and Source Corporation, Smartest Pronto Blood Glucose Monitoring System
K091815	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/20/2010
Arkray USA Inc. Assure Platinum Blood Glucose Monitoring System
K092104	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/12/2010
Fora Care Inc. TD-4251A No-Coding Blood Glucose Monitoring System
K092099	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/08/2010
Fora Care Inc. TD-4252C No-Coding Blood Glucose Monitoring System
K092099	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/08/2010
Fora Care Inc. TD-4253A No-Coding Blood Glucose Monitoring System
K092099	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/08/2010
Fora Care Inc. TD-4254A No-Coding Blood Glucose Monitoring System
K092099	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/08/2010
Acceava Mono Cassette  (For whole blood)
K961024	Infectious Mononucleosis Antibodies (Mono)	General Immunology	01/04/2010
Siemens, CLINITEK Status Connect System
K091216	Urine Qualitative Dipstick Ketone	Urinalysis	01/04/2010
Siemens, CLINITEK Status Connect System
K091216	Microalbumin	General Chemistry	01/04/2010
Siemens, CLINITEK Status Connect System
K091216	Urine Qualitative Dipstick Bilirubin	Urinalysis	01/04/2010
Siemens, CLINITEK Status Connect System
K091216	Urine Qualitative Dipstick Blood	Urinalysis	01/04/2010
Siemens, CLINITEK Status Connect System
K091216	Urine Qualitative Dipstick Glucose	Urinalysis	01/04/2010
Siemens, CLINITEK Status Connect System
K091216	Urine Qualitative Dipstick Leukocytes	Urinalysis	01/04/2010
Siemens, CLINITEK Status Connect System
K091216	Urine Qualitative Dipstick Nitrite	Urinalysis	01/04/2010
Siemens, CLINITEK Status Connect System
K091216	Urine Qualitative Dipstick Ph	Urinalysis	01/04/2010
Siemens, CLINITEK Status Connect System
K091216	Urine Qualitative Dipstick Protein	Urinalysis	01/04/2010
Siemens, CLINITEK Status Connect System
K091216	Urine Qualitative Dipstick Specific Gravity	Urinalysis	01/04/2010
Siemens, CLINITEK Status Connect System
K091216	Urine Qualitative Dipstick Creatinine	Urinalysis	01/04/2010
Siemens, CLINITEK Status Connect System
K091216	hCG, Urine	Endocrinology	01/04/2010
Siemens, CLINITEK Status+ Analyzer
K091216	Urine Qualitative Dipstick Ketone	Urinalysis	01/04/2010
Siemens, CLINITEK Status+ Analyzer
K091216	Microalbumin	General Chemistry	01/04/2010
Siemens, CLINITEK Status+ Analyzer
K091216	Urine Qualitative Dipstick Bilirubin	Urinalysis	01/04/2010
Siemens, CLINITEK Status+ Analyzer
K091216	Urine Qualitative Dipstick Blood	Urinalysis	01/04/2010
Siemens, CLINITEK Status+ Analyzer
K091216	Urine Qualitative Dipstick Glucose	Urinalysis	01/04/2010
Siemens, CLINITEK Status+ Analyzer
K091216	Urine Qualitative Dipstick Leukocytes	Urinalysis	01/04/2010
Siemens, CLINITEK Status+ Analyzer
K091216	Urine Qualitative Dipstick Nitrite	Urinalysis	01/04/2010
Siemens, CLINITEK Status+ Analyzer
K091216	Urine Qualitative Dipstick Ph	Urinalysis	01/04/2010
Siemens, CLINITEK Status+ Analyzer
K091216	Urine Qualitative Dipstick Protein	Urinalysis	01/04/2010
Siemens, CLINITEK Status+ Analyzer
K091216	Urine Qualitative Dipstick Specific Gravity	Urinalysis	01/04/2010
Siemens, CLINITEK Status+ Analyzer
K091216	Urine Qualitative Dipstick Creatinine	Urinalysis	01/04/2010
Siemens, CLINITEK Status+ Analyzer
K091216	hCG, Urine	Endocrinology	01/04/2010
Biotest Medical Corporation, SuperCheck1 Blood Glucose Monitoring System
K091815	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/10/2009
American Screening Corporation One Screen Drug Test Cards
K091588	Amphetamines	Toxicology / TDM	12/03/2009
American Screening Corporation One Screen Drug Test Cups
K091588	Amphetamines	Toxicology / TDM	12/03/2009
American Screening Corporation One Screen Drug Test Cups
K091588	Barbiturates	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cards
K091588	Cannabinoids (THC)	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cards
K091588	Phencyclidine (PCP)	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cards
K091588	Cocaine Metabolites	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cards
K091588	Opiates	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cards
K091588	Methadone	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cards
K091588	Methamphetamines	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cards
K091588	Benzodiazepines	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cards
K091588	Barbiturates	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cards
K091588	Morphine	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cards
K091588	Tricyclic Antidepressants	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cards
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cards
K091588	Oxycodone	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cups
K091588	Cannabinoids (THC)	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cups
K091588	Phencyclidine (PCP)	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cups
K091588	Cocaine Metabolites	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cups
K091588	Opiates	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cups
K091588	Methadone	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cups
K091588	Methamphetamines	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cups
K091588	Benzodiazepines	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cups
K091588	Morphine	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cups
K091588	Tricyclic Antidepressants	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cups
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	12/03/2009
American Screening Corporation OneScreen Drug Test Cups
K091588	Oxycodone	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Amphetamines	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Cannabinoids (THC)	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Phencyclidine (PCP)	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Cocaine Metabolites	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Opiates	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Methadone	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Methamphetamines	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Benzodiazepines	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Barbiturates	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Morphine	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Tricyclic Antidepressants	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	12/03/2009
Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards
K091588	Oxycodone	Toxicology / TDM	12/03/2009
Fora Care Inc. FORA D20/TD-3263 Blood Glucose Plus Blood Pressure Monitoring System
K091814	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/02/2009
Infopia USA LipidPro lipid profile and glucose measuring system
K090405	Triglyceride	General Chemistry	12/02/2009
Infopia USA LipidPro lipid profile and glucose measuring system
K090405	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/02/2009
Infopia USA LipidPro lipid profile and glucose measuring system
K090405	HDL Cholesterol	General Chemistry	12/02/2009
Infopia USA LipidPro lipid profile and glucose measuring system
K090405	Cholesterol	General Chemistry	12/02/2009
Infopia USA LipidPro lipid profile and glucose measuring system {LipidPro Lipid Profile test strips}
K090405	Triglyceride	General Chemistry	12/02/2009
Infopia USA LipidPro lipid profile and glucose measuring system {LipidPro Lipid Profile test strips}
K090405	HDL Cholesterol	General Chemistry	12/02/2009
Infopia USA LipidPro lipid profile and glucose measuring system {LipidPro Lipid Profile test strips}
K090405	Cholesterol	General Chemistry	12/02/2009
Cambridge Sensors ltd. microdot xtra Blood Glucose Monitoring System
K083273	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/23/2009
Conception Technologies hCG One Step Pregnancy Test Device (urine/serum)
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/17/2009
Infopia USA GLUCOLAB Auto-coding Blood Glucose Monitoring System
K091157	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/17/2009
Cardinal Health Leader Blood Glucose Monitoring System
K073573	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/13/2009
CLIAwaived, Inc. Rapid Fecal Occult Blood Test
K061065	Fecal Occult Blood	General Chemistry	11/09/2009
Princeton BioMeditech BioSign H. pylori WB {OSOM H. pylori} ((for whole blood)
K980798	Helicobacter Pylori Antibodies	General Immunology	11/09/2009
Arkray ReliOn Confirm Blood Glucose Monitoring System
K073416	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/30/2009
Arkray, GLUCOCARD VITAL Blood Glucose Monitoring System
K091102	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/30/2009
Nova Biomedical Corp. StatStrip Xpress Glucose Hosptial Meter
K070960	Glucose Monitoring Devices (Prescription Use Only)	General Chemistry	10/30/2009
Acon Mission U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Ketone	Urinalysis	10/28/2009
Acon Mission U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Bilirubin	Urinalysis	10/28/2009
Acon Mission U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Blood	Urinalysis	10/28/2009
Acon Mission U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Glucose	Urinalysis	10/28/2009
Acon Mission U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Leukocytes	Urinalysis	10/28/2009
Acon Mission U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Nitrite	Urinalysis	10/28/2009
Acon Mission U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Ph	Urinalysis	10/28/2009
Acon Mission U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Protein	Urinalysis	10/28/2009
Acon Mission U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Urobilinogen	Urinalysis	10/28/2009
Acon Mission U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Specific Gravity	Urinalysis	10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Ketone	Urinalysis	10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Bilirubin	Urinalysis	10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Blood	Urinalysis	10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Glucose	Urinalysis	10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Leukocytes	Urinalysis	10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Nitrite	Urinalysis	10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Ph	Urinalysis	10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Protein	Urinalysis	10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Urobilinogen	Urinalysis	10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer
K070929	Urine Qualitative Dipstick Specific Gravity	Urinalysis	10/28/2009
RefuAH U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Ketone	Urinalysis	10/28/2009
RefuAH U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Bilirubin	Urinalysis	10/28/2009
RefuAH U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Blood	Urinalysis	10/28/2009
RefuAH U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Glucose	Urinalysis	10/28/2009
RefuAH U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Leukocytes	Urinalysis	10/28/2009
RefuAH U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Nitrite	Urinalysis	10/28/2009
RefuAH U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Ph	Urinalysis	10/28/2009
RefuAH U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Protein	Urinalysis	10/28/2009
RefuAH U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Urobilinogen	Urinalysis	10/28/2009
RefuAH U120 Urine Analyzer
K070929	Urine Qualitative Dipstick Specific Gravity	Urinalysis	10/28/2009
Genzyme Diagnostics OSOM ImmunoDip Urinary Albumin Test
K022538	Albumin, Urinary	General Chemistry	10/26/2009
Fifty 50 Medical, Fifty 50 Glucose Monitoring System 2.0
K083468	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/14/2009
Major Biosystem Corp. AP-1000 Blood Glucose Monitoring System
K090389	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/14/2009
Fora Care Inc. FORA G90 Blood Glucose Monitoring System
K091898	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/30/2009
Fora Care Inc. U-Right TD-4234 Blood Glucose Monitoring System
K091898	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Amphetamines	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Cannabinoids (THC)	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Phencyclidine (PCP)	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Cocaine Metabolites	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Opiates	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Methadone	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Methamphetamines	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Benzodiazepines	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Barbiturates	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Morphine	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Tricyclic Antidepressants	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards
K091588	Oxycodone	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Amphetamines	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Cannabinoids (THC)	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Phencyclidine (PCP)	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Cocaine Metabolites	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Opiates	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Methadone	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Methamphetamines	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Benzodiazepines	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Barbiturates	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Morphine	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Tricyclic Antidepressants	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	09/30/2009
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups
K091588	Oxycodone	Toxicology / TDM	09/30/2009
CLIA waived inc Rapid STREP A Test
K023270	Streptococcus, Group A	Bacteriology	09/15/2009
Fora Care Inc. U-Right TD-4250 Blood Glucose Monitoring System
K083570	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/14/2009
Fora Care Inc. U-Right TD-4249 Blood Glucose Monitoring System
K083570	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer
K960546	Urine Qualitative Dipstick Ketone	Urinalysis	09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer
K960546	Urine Qualitative Dipstick Bilirubin	Urinalysis	09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer
K960546	Urine Qualitative Dipstick Blood	Urinalysis	09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer
K960546	Urine Qualitative Dipstick Glucose	Urinalysis	09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer
K960546	Urine Qualitative Dipstick Leukocytes	Urinalysis	09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer
K960546	Urine Qualitative Dipstick Nitrite	Urinalysis	09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer
K960546	Urine Qualitative Dipstick Ph	Urinalysis	09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer
K960546	Urine Qualitative Dipstick Protein	Urinalysis	09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer
K960546	Urine Qualitative Dipstick Urobilinogen	Urinalysis	09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer
K960546	Urine Qualitative Dipstick Specific Gravity	Urinalysis	09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer
K972706	Microalbumin	General Chemistry	09/14/2009
Siemens Clinitek 50 Urine Chemistry Analyzer
K972706	Creatinine	General Chemistry	09/14/2009
Bayer Contour USB Glucose Monitoring System
K091820	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/09/2009
Excel Medical Group Bio View hCG Pregnancy Serum/Urine Cassette and Dipstick Tests
K071030	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/09/2009
GERMAINE LABORATORIES AimStep Immunological Fecal Occult Blood Test (iFOBT)
K063693	Fecal Occult Blood	General Chemistry	09/09/2009
PSS CONSULT Diagnostic Occult Blood Test
K911075	Fecal Occult Blood	General Chemistry	09/09/2009
PSS CONSULT diagnostics Occult Blood Test-ES
K003359	Fecal Occult Blood	General Chemistry	09/09/2009
SCI International, Inc. Baby Test Pregnancy Test Cassette Format
K050741	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/09/2009
SCI International, Inc. U-Check Pregnancy Test Cassette Format
K050741	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/09/2009
Specialty Medical Supplies Vocal Point Blood Glucose Monitoring System
K083570	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/09/2009
Wiener Laboratories Urine Strip
K083724	Urine Qualitative Dipstick Ketone	Urinalysis	09/09/2009
Wiener Laboratories Urine Strip
K083724	Urine Qualitative Dipstick Bilirubin	Urinalysis	09/09/2009
Wiener Laboratories Urine Strip
K083724	Urine Qualitative Dipstick Blood	Urinalysis	09/09/2009
Wiener Laboratories Urine Strip
K083724	Urine Qualitative Dipstick Glucose	Urinalysis	09/09/2009
Wiener Laboratories Urine Strip
K083724	Urine Qualitative Dipstick Leukocytes	Urinalysis	09/09/2009
Wiener Laboratories Urine Strip
K083724	Urine Qualitative Dipstick Nitrite	Urinalysis	09/09/2009
Wiener Laboratories Urine Strip
K083724	Urine Qualitative Dipstick Ph	Urinalysis	09/09/2009
Wiener Laboratories Urine Strip
K083724	Urine Qualitative Dipstick Protein	Urinalysis	09/09/2009
Wiener Laboratories Urine Strip
K083724	Urine Qualitative Dipstick Urobilinogen	Urinalysis	09/09/2009
Wiener Laboratories Urine Strip
K083724	Urine Qualitative Dipstick Specific Gravity	Urinalysis	09/09/2009
Wiener Laboratories Urine Strip
K083724	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	09/09/2009
Guangzhou Wondfo Biotech One Step HCG Urine/Serum Test
K072500	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/03/2009
Arkray USA Inc. Assure Pro Blood Glucose Monitoring System
K090332	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/01/2009
EPS Bio Technology Corp. EasyPlus mini R13N Self-Monitoring Blood Glucose System
K091481	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/01/2009
Omnis Health Embrace No Code Blood Glucose Monitoring System
K090043	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/01/2009
Sacks Medical Corp., RefuAH Plus Blood Glucose Monitoring System
K090057	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/01/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Blood	Urinalysis	08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Ph	Urinalysis	08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Protein	Urinalysis	08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	08/24/2009
Sacks Medical Corporation RefuAH Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	08/24/2009
BinaxNOW Influenza A & B Test
K092223	Influenza A/B	Virology	08/18/2009
Diagnostic Test Group, Clarity Plus Blood Glucose Monitoring System
K090057	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/07/2009
Pro-Advantage by NDC H. Pylori Device {Whole Blood}
K024350	Helicobacter Pylori Antibodies	General Immunology	08/07/2009
Fora Care Inc. U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System
K090188	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/16/2009
Fora Care Inc., FORA V12 Blood Glucose Monitoring System
K090404	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/16/2009
Fora Care, Inc., FORA V10 Blood Glucose Monitoring System
K090404	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/16/2009
ProAdvantage by NDC Infectious Mononucleosis Test Device (Whole Blood Only)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	07/16/2009
U.S. Diagnostics Inc. ACURA Blood Glucose Monitoring System
K083468	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/16/2009
BTNX Inc. Rapid Response hCG Pregnancy Serum/Urine Test Strip
K974060	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/01/2009
Inverness Medical Innovations Signify ER Drug Screen
K041685	Amphetamines	Toxicology / TDM	07/01/2009
Inverness Medical Innovations Signify ER Drug Screen
K041685	Cannabinoids (THC)	Toxicology / TDM	07/01/2009
Inverness Medical Innovations Signify ER Drug Screen
K041685	Phencyclidine (PCP)	Toxicology / TDM	07/01/2009
Inverness Medical Innovations Signify ER Drug Screen
K041685	Cocaine Metabolites	Toxicology / TDM	07/01/2009
Inverness Medical Innovations Signify ER Drug Screen
K041685	Opiates	Toxicology / TDM	07/01/2009
Inverness Medical Innovations Signify ER Drug Screen
K041685	Propoxyphene	Toxicology / TDM	07/01/2009
Inverness Medical Innovations Signify ER Drug Screen
K041685	Benzodiazepines	Toxicology / TDM	07/01/2009
Inverness Medical Innovations Signify ER Drug Screen
K041685	Barbiturates	Toxicology / TDM	07/01/2009
Inverness Medical Innovations Signify ER Drug Screen
K041685	Tricyclic Antidepressants	Toxicology / TDM	07/01/2009
Inverness Medical Innovations Signify ER Drug Screen
K041685	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/01/2009
Inverness Medical Innovations Signify ER Drug Screen
K041685	Oxycodone	Toxicology / TDM	07/01/2009
Inverness Medical Innovations Signify hCG Urine Dipstick
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/01/2009
National Distribution and Contracting Inc., Pro Advantage by NDC Urine/Serum Pregnancy Cassette Device
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/01/2009
Turklab Rapidan Optima Early Test One Step hCG Urine Pregnancy Test for Home Use
K081150	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/01/2009
Turklab Toyo Diagnostics One Step hCG Urine Pregnancy Cassette Test
K081150	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/01/2009
Turklab Toyo Diagnostics One Step hCG Urine Pregnancy Strip Test for Home Use
K081150	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/01/2009
All Medicus Gluco Dr. Plus+ Blood Glucose Monitoring System
K082328	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/12/2009
Early Detect Inc., EarlyDETECT Pro hCG Urine pregnancy test card
K020968	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/12/2009
Early Detect Inc., EarlyDETECT Pro hCG Urine pregnancy test strip
K020968	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/12/2009
Fora Care FORA V22 Blood Glucose Monitoring System
K081609	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/12/2009
Fora Care Inc. U-Right TD-4225 Blood Glucose Monitoring System
K073494	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/12/2009
Stanbio HemoPoint H2 DM Hemoglobin Measurement System {with Data Management}
K090093	Hemoglobin	Hematology	06/12/2009
Diagnostic Devices Prodigy AutoCode Talking Blood Glucose Monitoring System
K073118	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/08/2009
Diagnostic Devices Prodigy Pocket Blood Glucose Monitoring System
K073118	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/08/2009
Diagnostic Devices Prodigy Voice Talking Blood Glucose Monitoring System
K073118	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/08/2009
National Distribution and Contracting Inc., Pro Advantage by NDC Urine Pregnancy Cassette Device
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/08/2009
Tyson Bioresearch Inc. Diachex+ Pro Blood Glucose Monitoring System
K090629	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/08/2009
Tyson Bioresearch Inc. Easy Step Blood Glucose Monitoring System
K090629	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/08/2009
Abbott OptiumEZ Blood Glucose Monitoring System
K081975	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/03/2009
CLIAwaived INC. Thyroid Test Rapid TSH Cassette  (Whole Blood)
K990658	Thyroid Stimulating Hormone (TSH)	Endocrinology	06/03/2009
Fora Care Inc. FORA V10 Blood Glucose Monitoring System
K081715	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/03/2009
Fora Care Inc. FORA G30 Blood Glucose Monitoring System
K090187	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/29/2009
EarlyDETECT H. PYLORI WHOLE BLOOD RAPID TEST
K024360	Helicobacter Pylori	Bacteriology	05/21/2009
IMI Signify Strep A Dipstick {Inverness Medical Innovations}
K010582	Streptococcus, Group A	Bacteriology	05/21/2009
Inverness Medical SIGNIFY H. PYLORI WHOLE BLOOD
K024350	Helicobacter Pylori Antibodies	General Immunology	05/21/2009
Inverness Medical Signify Strep A Cassette {Inverness Medical Innovations}
K031784	Streptococcus, Group A	Bacteriology	05/21/2009
Twin Spirit, Inc. DrugSmart Cup
K082898	Amphetamines	Toxicology / TDM	05/11/2009
Twin Spirit, Inc. DrugSmart Cup
K082898	Cannabinoids (THC)	Toxicology / TDM	05/11/2009
Twin Spirit, Inc. DrugSmart Cup
K082898	Phencyclidine (PCP)	Toxicology / TDM	05/11/2009
Twin Spirit, Inc. DrugSmart Cup
K082898	Cocaine Metabolites	Toxicology / TDM	05/11/2009
Twin Spirit, Inc. DrugSmart Cup
K082898	Opiates	Toxicology / TDM	05/11/2009
Twin Spirit, Inc. DrugSmart Cup
K082898	Methadone	Toxicology / TDM	05/11/2009
Twin Spirit, Inc. DrugSmart Cup
K082898	Methamphetamines	Toxicology / TDM	05/11/2009
Twin Spirit, Inc. DrugSmart Cup
K082898	Benzodiazepines	Toxicology / TDM	05/11/2009
Twin Spirit, Inc. DrugSmart Cup
K082898	Barbiturates	Toxicology / TDM	05/11/2009
Twin Spirit, Inc. DrugSmart Cup
K082898	Tricyclic Antidepressants	Toxicology / TDM	05/11/2009
Twin Spirit, Inc. DrugSmart Cup
K082898	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/11/2009
Twin Spirit, Inc. DrugSmart Cup
K082898	Oxycodone	Toxicology / TDM	05/11/2009
All Medicus GlucoDr auto Blood Glucose Test System
K083628	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/07/2009
1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II
K050878	Amphetamines	Toxicology / TDM	04/30/2009
1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II
K050878	Cannabinoids (THC)	Toxicology / TDM	04/30/2009
1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II
K050878	Phencyclidine (PCP)	Toxicology / TDM	04/30/2009
1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II
K050878	Cocaine Metabolites	Toxicology / TDM	04/30/2009
1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II
K050878	Opiates	Toxicology / TDM	04/30/2009
1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II
K050878	Methamphetamine/Amphetamine	Toxicology / TDM	04/30/2009
1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II
K050878	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	04/30/2009
Acon Laboratories, On-Call Plus Blood Glucose Monitoring System
K090057	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/30/2009
BTNX Inc. Rapid Response hCG Pregnancy Test (Midstream)
K974059	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/30/2009
Home Diagnostics, TRUEbalance Blood Glucose Monitoring System
K090495	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/30/2009
Inverness Medical Innovations Signify hCG Combo Cassette
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/30/2009
The Kroger Co. Kroger Blood Glucose Monitoring System
K073573	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/30/2009
Abbott ReliOn Ultima Blood Glucose Monitoring System
K083223	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/22/2009
AgaMatrix WaveSense Presto Pro Blood Glucose Monitoring System
K073573	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/22/2009
National Diagnostic Products Betachek Blood Glucose (Sugar) Test
K062187	Whole Blood Qualitative Dipstick Glucose	General Chemistry	04/22/2009
Fora Care Inc. FORA V12 No-Coding Blood Glucose Monitoring System
K090536	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/16/2009
Acceava Mono II  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	04/14/2009
CLIAwaived Inc. Pregnancy Combo Test (Cassette)
K984077	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/06/2009
CLIAwaived Inc. Pregnancy Combo Test (Dip-Strip)
K984080	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/06/2009
Acceava Strep A Twist Rapid Test {Streptococcus, Group A}
K010582	Streptococcus, Group A	Bacteriology	04/01/2009
Consult Diagnostics STREP A RAPID Dipstick {Streptococcuc, Group A}
K010582	Streptococcus, Group A	Bacteriology	04/01/2009
MEC Dynamics Avie A1c Test System
K081269	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	04/01/2009
Amerifit Inc Azo Test Strips Urinary Tract Infection Test
K063295	Nitrite, Urine	General Chemistry	03/16/2009
Amerifit Inc Azo Test Strips Urinary Tract Infection Test
K063295	Leukocyte Esterase, Urinary	Urinalysis	03/16/2009
BTNX Inc. Rapid Response hCG Pregnancy Test Cassette Format
K050741	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/16/2009
BTNX Inc. Rapid Response Pregnancy Test Strip Format
K951705	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/16/2009
Lil' Drug Store Products Inc. Vagi-Screen Vaginal Health Test
X080117	pH	General Chemistry	03/16/2009
MACHEREY-NAGEL Medi-Test Glucose
K991927	Urine Qualitative Dipstick Glucose	Urinalysis	03/16/2009
Innovacon, Inc. One Step hCG Single Test Card
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/12/2009
PSS World Medical, Inc. Consult Diagnostics hCG Combo Cassette
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/12/2009
Amedica Biotech Amedica Drug Screen Test Cup
K082898	Amphetamines	Toxicology / TDM	03/10/2009
Amedica Biotech Amedica Drug Screen Test Cup
K082898	Cannabinoids (THC)	Toxicology / TDM	03/10/2009
Amedica Biotech Amedica Drug Screen Test Cup
K082898	Phencyclidine (PCP)	Toxicology / TDM	03/10/2009
Amedica Biotech Amedica Drug Screen Test Cup
K082898	Cocaine Metabolites	Toxicology / TDM	03/10/2009
Amedica Biotech Amedica Drug Screen Test Cup
K082898	Opiates	Toxicology / TDM	03/10/2009
Amedica Biotech Amedica Drug Screen Test Cup
K082898	Methadone	Toxicology / TDM	03/10/2009
Amedica Biotech Amedica Drug Screen Test Cup
K082898	Methamphetamines	Toxicology / TDM	03/10/2009
Amedica Biotech Amedica Drug Screen Test Cup
K082898	Benzodiazepines	Toxicology / TDM	03/10/2009
Amedica Biotech Amedica Drug Screen Test Cup
K082898	Barbiturates	Toxicology / TDM	03/10/2009
Amedica Biotech Amedica Drug Screen Test Cup
K082898	Tricyclic Antidepressants	Toxicology / TDM	03/10/2009
Amedica Biotech Amedica Drug Screen Test Cup
K082898	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	03/10/2009
Amedica Biotech Amedica Drug Screen Test Cup
K082898	Oxycodone	Toxicology / TDM	03/10/2009
EarlyDetect Pro Influenza A Test
K041441	Influenza A	Virology	03/10/2009
EarlyDetect Pro Influenza B Test
K041439	Influenza B	Virology	03/10/2009
PSS World Medical, Inc. Consult Diagnostics hCG Dipstick
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/10/2009
PSS World Medical, Inc. Consult Diagnostics hCG Urine Cassette
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/10/2009
Henry Schein OneStep+ iFOBT
K060463	Fecal Occult Blood	General Chemistry	03/05/2009
lifeSign Status-COLON ASSURE Guaiac Test
K902360	Fecal Occult Blood	General Chemistry	03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Ketone	Urinalysis	03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer
K031947	Microalbumin	General Chemistry	03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Bilirubin	Urinalysis	03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Blood	Urinalysis	03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Glucose	Urinalysis	03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Leukocytes	Urinalysis	03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Nitrite	Urinalysis	03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Ph	Urinalysis	03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Protein	Urinalysis	03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Specific Gravity	Urinalysis	03/05/2009
Siemens Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Creatinine	Urinalysis	03/05/2009
US Diagnostics, Inc. Infinity Blood Glucose Monitoring System
K082201	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/25/2009
Home Diagnostics GRACEtrack Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/18/2009
InfopiaUSA, LLC Duo-Max Blood Pressure and Glucose Monitoring System, Model HMF-100
K080636	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/18/2009
i-SENS, Inc. CareSens N Blood Glucose Monitoring System
K083468	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/12/2009
Fora Care Inc. FORA TD-4251 Blood Glucose Monitoring System
K082482	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/03/2009
Fora Care Inc. U-Right TD-4252A Blood Glucose Monitoring System
K082482	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/03/2009
Fora Care Inc. U-Right TD-4252B Blood Glucose Monitoring System
K082482	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/03/2009
Fora Care Inc. U-Right TD-4254 Blood Glucose Monitoring System
K082482	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/03/2009
AgaMatrix WaveSense AMP Blood Glucose Monitoring System
K073573	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/02/2009
Roche Diagnostics Accutrend Plus System  (fingerstick whole blood)
K051376	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/29/2009
Roche Diagnostics Accutrend Plus System  (fingerstick whole blood)
K051376	Cholesterol	General Chemistry	01/29/2009
EPS Bio Technology Corp. EasyPlus mini R2N Self-Monitoring Blood Glucose Test System
K081796	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/27/2009
EPS Bio Technology EasyMax N Self Monitoring Blood Glucose Test System
K083099	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/27/2009
BTNX Rapid Response hCG Pregnancy Urine Cassette and Dipstick Tests
K070921	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/26/2009
IM Diagnostics, Inc. IM Confirms II hCG Pregnancy Urine Cassette and Dipstick Tests
K070921	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/26/2009
Siemens Clinitek Status Urine Chemistry Analyzer
K032563	hCG, Urine	Endocrinology	01/26/2009
Card Guard Scientific Survival, Ltd. PMP4 Easy2Check Personal Wireless Blood Pressure and Blood Glucose Monitoring System
K082521	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/22/2009
Cliawaived, Inc. CLIAWAIVED H. PYLORI WHOLE BLOOD RAPID TEST
K024360	Helicobacter Pylori Antibodies	General Immunology	01/22/2009
Conception Technologies hCG One Step Pregnancy Test Device (urine)
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/22/2009
Infopia USA Envision Autocode Blood Glucose Monitoring System
K082020	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/15/2009
Fora Care Inc. FORA TD-4245 Blood Glucose Monitoring System
K083664	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/12/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Blood	Urinalysis	01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Ph	Urinalysis	01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Protein	Urinalysis	01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	01/09/2009
Entra Health Systems, Ltd., MyGlucoHealth Glucose Monitoring System
K081703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/09/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489	Amphetamines	Toxicology / TDM	01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489	Phencyclidine (PCP)	Toxicology / TDM	01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489	Cocaine Metabolites	Toxicology / TDM	01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489	Methadone	Toxicology / TDM	01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489	Methamphetamines	Toxicology / TDM	01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489	Benzodiazepines	Toxicology / TDM	01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489	Barbiturates	Toxicology / TDM	01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489	Morphine	Toxicology / TDM	01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489	Tricyclic Antidepressants	Toxicology / TDM	01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489	Oxycodone	Toxicology / TDM	01/07/2009
Avnetir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489	Cannabinoids (THC)	Toxicology / TDM	01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489	Amphetamines	Toxicology / TDM	01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489	Cannabinoids (THC)	Toxicology / TDM	01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489	Phencyclidine (PCP)	Toxicology / TDM	01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489	Cocaine Metabolites	Toxicology / TDM	01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489	Methadone	Toxicology / TDM	01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489	Methamphetamines	Toxicology / TDM	01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489	Benzodiazepines	Toxicology / TDM	01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489	Barbiturates	Toxicology / TDM	01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489	Morphine	Toxicology / TDM	01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489	Tricyclic Antidepressants	Toxicology / TDM	01/07/2009
Clia Waived.com CLIA-X Mulitple Drug Cup Test  (Professional version)
K071489	Oxycodone	Toxicology / TDM	01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489	Amphetamines	Toxicology / TDM	01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489	Cannabinoids (THC)	Toxicology / TDM	01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489	Phencyclidine (PCP)	Toxicology / TDM	01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489	Cocaine Metabolites	Toxicology / TDM	01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489	Methadone	Toxicology / TDM	01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489	Methamphetamines	Toxicology / TDM	01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489	Benzodiazepines	Toxicology / TDM	01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489	Barbiturates	Toxicology / TDM	01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489	Morphine	Toxicology / TDM	01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489	Tricyclic Antidepressants	Toxicology / TDM	01/07/2009
Syntron Bioresearch Quikscreen Multiple Drug Cup Test  (Professional version)
K071489	Oxycodone	Toxicology / TDM	01/07/2009
Amedica Biotech The Amedica Home Drug Test Cup
K082898	Amphetamines	Toxicology / TDM	01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup
K082898	Cannabinoids (THC)	Toxicology / TDM	01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup
K082898	Phencyclidine (PCP)	Toxicology / TDM	01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup
K082898	Cocaine Metabolites	Toxicology / TDM	01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup
K082898	Opiates	Toxicology / TDM	01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup
K082898	Methadone	Toxicology / TDM	01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup
K082898	Methamphetamines	Toxicology / TDM	01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup
K082898	Benzodiazepines	Toxicology / TDM	01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup
K082898	Barbiturates	Toxicology / TDM	01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup
K082898	Tricyclic Antidepressants	Toxicology / TDM	01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup
K082898	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup
K082898	Oxycodone	Toxicology / TDM	01/05/2009
BTNX Inc. Rapid Response hCG Pregnancy Serum/Urine Test Cassette and Dipstick Tests
K071030	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/05/2009
BTNX Inc. Rapid Response hCG Pregnancy Test 2000 mIU/mL
K052694	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/05/2009
CLIAwaived Inc. Pregnancy Urine Test (Dip-strip)
K984079	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/05/2009
CLIAwaived, Inc. Pregnancy Urine Test (Cassette)
K984076	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Ketone	Urinalysis	01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Bilirubin	Urinalysis	01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Blood	Urinalysis	01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Glucose	Urinalysis	01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Leukocytes	Urinalysis	01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Nitrite	Urinalysis	01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Ph	Urinalysis	01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Protein	Urinalysis	01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Urobilinogen	Urinalysis	01/05/2009
Cole Taylor Marketing, Inc. CTMI Urine Reagent Strips for Urinalysis
K970250	Urine Qualitative Dipstick Specific Gravity	Urinalysis	01/05/2009
Fora Care Inc. FORA D15c Blood Glucose Plus Pressure Monitoring System
K062800	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/05/2009
Fora Care Inc. FORA TD-4244 Blood Glucose Monitoring System
K081715	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips
K991927	Urine Qualitative Dipstick Ketone	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips
K991927	Urine Qualitative Dipstick Bilirubin	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips
K991927	Urine Qualitative Dipstick Blood	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips
K991927	Urine Qualitative Dipstick Glucose	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips
K991927	Urine Qualitative Dipstick Leukocytes	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips
K991927	Urine Qualitative Dipstick Nitrite	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips
K991927	Urine Qualitative Dipstick Ph	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips
K991927	Urine Qualitative Dipstick Protein	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips
K991927	Urine Qualitative Dipstick Urobilinogen	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS 10 Urine Reagent Strips
K991927	Urine Qualitative Dipstick Specific Gravity	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader
K061742	Urine Qualitative Dipstick Ketone	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader
K061742	Urine Qualitative Dipstick Bilirubin	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader
K061742	Urine Qualitative Dipstick Blood	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader
K061742	Urine Qualitative Dipstick Glucose	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader
K061742	Urine Qualitative Dipstick Leukocytes	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader
K061742	Urine Qualitative Dipstick Nitrite	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader
K061742	Urine Qualitative Dipstick Ph	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader
K061742	Urine Qualitative Dipstick Protein	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader
K061742	Urine Qualitative Dipstick Urobilinogen	Urinalysis	01/05/2009
Jant Pharmacal Corporation Accustrip URS Reader
K061742	Urine Qualitative Dipstick Specific Gravity	Urinalysis	01/05/2009
ReliOn micro Blood Glucose Monitoring System
K082417	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/05/2009
SCI International Inc. New Choice Pro hCG Pregnancy Test Cassette Format
K050741	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/05/2009
SCI International Inc. New Choice Pro Pregnancy Test Strip Format
K951705	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/05/2009
Tyson Bioresearch, Inc., Diachex+ Evolve Blood Glucose Monitoring System
K073492	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/18/2008
Fora Care Inc. FORA D15b Blood Glucose Plus Blood Pressure Monitoring System
K080014	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2008
Fora Care Inc. FORA D15z Blood Glucose Plus Blood Pressure Monitoring System
K080014	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2008
SCI International Inc. New Choice Pro hCG Pregnancy Test 2000 mIU/mL Cassette Format
K052694	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/17/2008
Abbott ReliOn Ultima Advance Blood Glucose Monitoring System
K081975	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/08/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K950164	Calcium, Total	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782	Albumin	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782	Glucose	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782	Creatinine	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782	Urea (BUN)	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782	Glucose	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782	Potassium	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782	Creatinine	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782	Urea (BUN)	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K992140	Potassium	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K992140	Carbon Dioxide, Total (CO2)	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K992140	Creatine Kinase (CK)	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K992140	Carbon Dioxide, Total (CO2)	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K993211	Sodium	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K993211	Sodium	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K010670	chloride	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K010670	chloride	General Chemistry	12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K022312	Phosphorus	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K022312	Phosphorus	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K010670	chloride	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K010670	chloride	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K993211	Sodium	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K993211	Sodium	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K992140	Creatine Kinase (CK)	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K992140	Carbon Dioxide, Total (CO2)	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K992140	Potassium	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K992140	Carbon Dioxide, Total (CO2)	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782	Glucose	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782	Potassium	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782	Creatinine	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782	Urea (BUN)	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782	Albumin	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782	Glucose	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782	Creatinine	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782	Urea (BUN)	General Chemistry	12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K950164	Calcium, Total	General Chemistry	12/04/2008
Jant Pharmacal Accutest Dual Sample Immunological Fecal Occult Blood (iFOB) Test
K073431	Fecal Occult Blood	General Chemistry	12/04/2008
Jant Pharmacal Accutest Immunological Fecal Occult Blood Test (iFOBT)
K063693	Fecal Occult Blood	General Chemistry	12/04/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Blood	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Ph	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Protein	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 11SG Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Blood	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Protein	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Blood	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Ph	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Protein	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Blood	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Ph	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Protein	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Blood	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Ph	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Protein	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	11/21/2008
Diagnostic Test Group Clarity Urocheck Blood Urine Reagent Strips for Urinalysis
K061559	Urine Qualitative Dipstick Blood	Urinalysis	11/21/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110	Hemoglobin	Hematology	11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110	Glucose	General Chemistry	11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110	Sodium	General Chemistry	11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110	Potassium	General Chemistry	11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110	Urea (BUN)	General Chemistry	11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110	chloride	General Chemistry	11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110	Hematocrit	Hematology	11/13/2008
Abbott i-STAT Crea Cartridge  (Venous Whole blood)
K053110	Creatinine	General Chemistry	11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous Whole blood)
K053110	Hemoglobin	Hematology	11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous Whole blood)
K053110	Sodium	General Chemistry	11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous Whole blood)
K053110	Potassium	General Chemistry	11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous Whole blood)
K053110	Hematocrit	Hematology	11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110	Hemoglobin	Hematology	11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110	Glucose	General Chemistry	11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110	Sodium	General Chemistry	11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110	Potassium	General Chemistry	11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110	Hematocrit	Hematology	11/13/2008
Abbott i-STAT G Cartridge  (Venous Whole blood)
K053110	Glucose	General Chemistry	11/13/2008
Fora Care Inc. FORA D-10 Blood Glucose plus Blood Pressure Monitoring System
K081714	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/13/2008
Nova Biomedical Nova Gold Blood Glucose Monitoring System
K070255	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/13/2008
Siemens DCA 2000 analyzer
K951361	Glycated Hemoglobin, Total	General Chemistry	11/13/2008
Siemens DCA 2000+ analyzer
K951361	Glycated Hemoglobin, Total	General Chemistry	11/13/2008
Common Sense Ltd. Norma-Sense Vaginal Discharge pH Test
X070057	pH, Urine	General Chemistry	11/04/2008
IM Diagnostics, Inc. IM Maxie 2 hCG Pregnancy Urine Cassette and Dipstick Tests
K070921	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/04/2008
Mossman Associates, Inc. NicCheck I Test Strips
K963733	Nicotine And/Or Metabolites	Toxicology / TDM	11/04/2008
Wako APOLOWAKO Analyzer {Whole Blood}
K080123	Glucose	General Chemistry	10/31/2008
Wako APOLOWAKO Analyzer {Whole Blood}
K080123	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	10/31/2008
Wako APOLOWAKO Analyzer  (Whole Blood)
K080125	Triglyceride	General Chemistry	10/31/2008
Wako APOLOWAKO Analyzer  (Whole Blood)
K080125	Cholesterol	General Chemistry	10/31/2008
IM Diagnostics, Inc. IM Confirms II plus hCG Pregnancy Serum/Urine Cassette and Dipstick Tests
K071030	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/28/2008
Arkray USA, Inc. GLUCOCARD 01-mini Blood Glucose Monitoring System
K082417	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/23/2008
i-SENS, Inc. CareSens II Blood Glucose Monitoring System
K080923	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/23/2008
i-SENS, Inc. CareSens POP Blood Glucose Monitoring System
K080923	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/23/2008
LifeScan OneTouch Vita Blood Glucose Monitoring System
K082513	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/23/2008
Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System
K080960	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/17/2008
Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System
K080960	Ketone, Blood	General Chemistry	10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)
K061559	Urine Qualitative Dipstick Blood	Urinalysis	10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)
K061559	Urine Qualitative Dipstick Ph	Urinalysis	10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)
K061559	Urine Qualitative Dipstick Protein	Urinalysis	10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	10/17/2008
Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)
K061559	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	10/17/2008
Arkray USA, Inc. Assure 4 Blood Glucose Monitoring System
K070088	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip
K970250	Urine Qualitative Dipstick Ketone	Urinalysis	10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip
K970250	Urine Qualitative Dipstick Bilirubin	Urinalysis	10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip
K970250	Urine Qualitative Dipstick Blood	Urinalysis	10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip
K970250	Urine Qualitative Dipstick Glucose	Urinalysis	10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip
K970250	Urine Qualitative Dipstick Leukocytes	Urinalysis	10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip
K970250	Urine Qualitative Dipstick Nitrite	Urinalysis	10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip
K970250	Urine Qualitative Dipstick Ph	Urinalysis	10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip
K970250	Urine Qualitative Dipstick Protein	Urinalysis	10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip
K970250	Urine Qualitative Dipstick Urobilinogen	Urinalysis	10/17/2008
BTNX Rapid Response 10-SG Urinalysis Reagent Strip
K970250	Urine Qualitative Dipstick Specific Gravity	Urinalysis	10/17/2008
Consult diagnostics Urine Analyzer
K050801	Urine Qualitative Dipstick Ketone	Urinalysis	10/17/2008
Consult diagnostics Urine Analyzer
K050801	Urine Qualitative Dipstick Bilirubin	Urinalysis	10/17/2008
Consult diagnostics Urine Analyzer
K050801	Urine Qualitative Dipstick Blood	Urinalysis	10/17/2008
Consult diagnostics Urine Analyzer
K050801	Urine Qualitative Dipstick Glucose	Urinalysis	10/17/2008
Consult diagnostics Urine Analyzer
K050801	Urine Qualitative Dipstick Leukocytes	Urinalysis	10/17/2008
Consult diagnostics Urine Analyzer
K050801	Urine Qualitative Dipstick Nitrite	Urinalysis	10/17/2008
Consult diagnostics Urine Analyzer
K050801	Urine Qualitative Dipstick Ph	Urinalysis	10/17/2008
Consult diagnostics Urine Analyzer
K050801	Urine Qualitative Dipstick Protein	Urinalysis	10/17/2008
Consult diagnostics Urine Analyzer
K050801	Urine Qualitative Dipstick Urobilinogen	Urinalysis	10/17/2008
Consult diagnostics Urine Analyzer
K050801	Urine Qualitative Dipstick Specific Gravity	Urinalysis	10/17/2008
Vertex Diagnostics UltraTRAK PRO Blood Glucose Monitoring System
K082618	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/17/2008
Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM100
K081451	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/25/2008
QUIDEL QUICKVUE DIPSTICK STREP A  (DIRECT THROAT SWAB)
K011097	Streptococcus, Group A	Bacteriology	09/25/2008
Quidel QuickVue In-Line Strep A  (direct from throat swab)
K934484	Streptococcus, Group A	Bacteriology	09/25/2008
Quidel QuickVue Influenza A+B Test
K053146	Influenza A/B	Virology	09/25/2008
Quidel QuickVue Influenza Test
K991633	Influenza A/B	Virology	09/25/2008
Quidel QuickVue RSV Test
K061008	Respiratory Syncytial Virus	Virology	09/25/2008
Quidel QuickVue RSV Test
K070747	Respiratory Syncytial Virus	Virology	09/25/2008
Common Sense Ltd. VA-SENSE Kit
X070058	Vaginal pH	General Chemistry	09/18/2008
EPS Bio Technology EasyPlus mini EasyMax self monitoring blood glucose system
K082121	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/18/2008
Fora Comfort 2 in 1 TD-3250C Blood Glucose and Blood Pressure Monitoring System
K080014	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/18/2008
Fora Comfort 2 in 1 TD-3260 Blood Glucose Plus Blood Pressure Monitoring System
K080014	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K052719	Urine Qualitative Dipstick Ketone	Urinalysis	09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K052719	Urine Qualitative Dipstick Bilirubin	Urinalysis	09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K052719	Urine Qualitative Dipstick Blood	Urinalysis	09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K052719	Urine Qualitative Dipstick Glucose	Urinalysis	09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K052719	Urine Qualitative Dipstick Leukocytes	Urinalysis	09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K052719	Urine Qualitative Dipstick Nitrite	Urinalysis	09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K052719	Urine Qualitative Dipstick Ph	Urinalysis	09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K052719	Urine Qualitative Dipstick Protein	Urinalysis	09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K052719	Urine Qualitative Dipstick Urobilinogen	Urinalysis	09/18/2008
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K052719	Urine Qualitative Dipstick Specific Gravity	Urinalysis	09/18/2008
PSS World Medical QUINTET Blood Glucose Monitoring System
K072054	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/18/2008
Taidoc Clever Chek TD-3250C Blood Glucose and Blood Pressure Monitoring System
K080014	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/18/2008
Taidoc Clever Chek TD-3250D Blood Glucose and Blood Pressure Monitoring System
K080014	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/18/2008
Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM110
K081450	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/12/2008
Andon Health Co., Ltd., andon AG-605 Blood Glucose Monitoring System
K073030	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/04/2008
Andon Health Co., Ltd., andon AG-606 Blood Glucose Monitoring System
K073030	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/04/2008
Home Diagnostics TRUEresult Blood Glucose Monitoring System
K080641	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/20/2008
Acon Laboratories Mission UTI Urinary Tract Infection Test Strips
K063295	Nitrite, Urine	General Chemistry	08/18/2008
Acon Laboratories Mission UTI Urinary Tract Infection Test Strips
K063295	Leukocyte Esterase, Urinary	Urinalysis	08/18/2008
American Bio Medica Rapid TOX
K053359	Amphetamines	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Cannabinoids (THC)	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Phencyclidine (PCP)	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Cocaine Metabolites	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Opiates	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Methadone	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Propoxyphene	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Methamphetamines	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Benzodiazepines	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Barbiturates	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Tricyclic Antidepressants	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Oxycodone	Toxicology / TDM	08/18/2008
American Bio Medica Rapid TOX
K053359	Buprenorphine	Toxicology / TDM	08/18/2008
Home Diagnostics TRUE2go Blood Glucose Monitoring System
K080710	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/15/2008
Inverness Medical Acceava hCG Urine II
K062361	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/14/2008
Home Diagnostics, Home Care Delivered TrueTrack Smart System Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/07/2008
Home Diagnostics, Moore Medical TrueTrack Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/07/2008
Home Diagnostics, TrueTrack for Rite Aid Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/07/2008
Home Diagnostics, TrueTrack Live Better Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/07/2008
TaiDoc Technology Corporation U-Right TD-4247 Blood Glucose Monitoring System
K081957	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/07/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test
K071489	Amphetamines	Toxicology / TDM	07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test
K071489	Phencyclidine (PCP)	Toxicology / TDM	07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test
K071489	Cocaine Metabolites	Toxicology / TDM	07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test
K071489	Methadone	Toxicology / TDM	07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test
K071489	Methamphetamines	Toxicology / TDM	07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test
K071489	Benzodiazepines	Toxicology / TDM	07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test
K071489	Barbiturates	Toxicology / TDM	07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test
K071489	Morphine	Toxicology / TDM	07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test
K071489	Tricyclic Antidepressants	Toxicology / TDM	07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test
K071489	Oxycodone	Toxicology / TDM	07/31/2008
Avnetir Biotech LLC Home Check Multiple Drug Cup Test
K071489	Cannabinoids (THC)	Toxicology / TDM	07/31/2008
Fora Care AudioChek Talking Mointors Blood Glucose Monitoring System Model TD-4237
K081609	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/30/2008
Fora Care Clever Chek TD-4237 Blood Glucose Monitoring System
K081609	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/30/2008
Fora Care Inc. FORA TD-3224 Blood Glucose Plus Blood Pressure Monitoring System
K081714	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/30/2008
Gluco Perfect LLC, Perfect Mini Blood Glucose Monitoring System
K052818	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/30/2008
BTNX Inc. Rapid Response Immunological Fecal Occult Blood Test (IFOBT)
K061065	Fecal Occult Blood	General Chemistry	07/22/2008
Healthcare Provider Direct OneStep Fecal Occult Blood (FOB) Screen Card Test
K063693	Fecal Occult Blood	General Chemistry	07/22/2008
Roche Diagnostics ACCU-CHEK Compact Plus Blood Glucose Meter
K081389	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/22/2008
Arkray USA, Inc. GLUCOCARD 01 Blood Glucose Monitoring System
K073416	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/17/2008
Henry Schein One Step+ Strep A Dipstick Test
K010582	Streptococcus, Group A	Bacteriology	07/17/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips
K051727	Urine Qualitative Dipstick Ketone	Urinalysis	07/14/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	07/14/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips
K051727	Urine Qualitative Dipstick Leukocytes	Urinalysis	07/14/2008
Germaine Laboratories Inc. AimStrip Urine Reagent Strips
K051727	Urine Qualitative Dipstick Nitrite	Urinalysis	07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips
K051727	Urine Qualitative Dipstick Bilirubin	Urinalysis	07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips
K051727	Urine Qualitative Dipstick Blood	Urinalysis	07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips
K051727	Urine Qualitative Dipstick Protein	Urinalysis	07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips
K051727	Urine Qualitative Dipstick Ph	Urinalysis	07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips
K051727	Urine Qualitative Dipstick Urobilinogen	Urinalysis	07/14/2008
Germaine Laboratories, Inc. AimStrip Urine Reagent Strips
K051727	Urine Qualitative Dipstick Specific Gravity	Urinalysis	07/14/2008
Inverness Medical Acceava hCG Basic II
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/14/2008
Inverness Medical Acceava hCG Combo II
K062361	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/14/2008
BECKMAN COULTER HEMOCCULT ICT
K080812	Fecal Occult Blood	General Chemistry	07/01/2008
Germaine Laboratories Compliance Gold iFOB (immunological fecal occult blood)Test
K063693	Fecal Occult Blood	General Chemistry	07/01/2008
IDEAL LIFE Gluco-Manager GMM 0001 Blood Glucose Monitoring System
K080283	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/30/2008
Tyson Bioresearch Inc. Diachex Basic Blood Glucose Monitoring System
K072854	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/30/2008
Tyson Bioresearch Inc. Diachex Superb Blood Glucose Monitoring System
K072854	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/30/2008
Tyson Bioresearch Inc. Diachex Vigor Blood Glucose Monitoring System
K072854	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/30/2008
Germaine Laboratories AimStrip Pregnancy
K974368	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/26/2008
AZO Test Strips Urinary Tract Infection Test
K063295	Nitrite, Urine	General Chemistry	06/25/2008
AZO Test Strips Urinary Tract Infection Test
K063295	Leukocyte Esterase, Urinary	Urinalysis	06/25/2008
Simple Diagnostics Clever Chek Auto-Code Voice Blood Glucose Monitoring System
K081144	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/23/2008
HemoCue Albumin 201 System
K053253	Albumin, Urinary	General Chemistry	06/13/2008
SpermCheck Vasectomy
K073039	Semen	Hematology	06/12/2008
Henry Schein OneStepPlus Urine Analyzer
K061742	Urine Qualitative Dipstick Ketone	Urinalysis	05/28/2008
Henry Schein OneStepPlus Urine Analyzer
K061742	Urine Qualitative Dipstick Bilirubin	Urinalysis	05/28/2008
Henry Schein OneStepPlus Urine Analyzer
K061742	Urine Qualitative Dipstick Blood	Urinalysis	05/28/2008
Henry Schein OneStepPlus Urine Analyzer
K061742	Urine Qualitative Dipstick Glucose	Urinalysis	05/28/2008
Henry Schein OneStepPlus Urine Analyzer
K061742	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/28/2008
Henry Schein OneStepPlus Urine Analyzer
K061742	Urine Qualitative Dipstick Nitrite	Urinalysis	05/28/2008
Henry Schein OneStepPlus Urine Analyzer
K061742	Urine Qualitative Dipstick Ph	Urinalysis	05/28/2008
Henry Schein OneStepPlus Urine Analyzer
K061742	Urine Qualitative Dipstick Protein	Urinalysis	05/28/2008
Henry Schein OneStepPlus Urine Analyzer
K061742	Urine Qualitative Dipstick Urobilinogen	Urinalysis	05/28/2008
Henry Schein OneStepPlus Urine Analyzer
K061742	Urine Qualitative Dipstick Specific Gravity	Urinalysis	05/28/2008
Henry Schein OneStepPlus Urine Analyzer
K061742	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	05/28/2008
Specialty Medical Supplies SureChek Edge Blood Glucose Monitoring System
K080501	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/28/2008
Taidoc Technology ACHTUNG TD-4207 No Code Blood Glucose Monitoring System
K073494	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/28/2008
Taidoc Technology CLEVER CHEK TD-4209 One-Code Blood Glucose Monitoring System
K073494	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/28/2008
TaiDoc Technology CLEVER CHEK TD-4222 No Code Blood Glucose Monitoring System
K073494	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/28/2008
Taidoc Technology CLEVER CHEK TD-4225 No Code Blood Glucose Monitoring System
K073494	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/28/2008
Taidoc Technology CLEVER CHEK TD-4226 One-Code Blood Glucose Monitoring System
K073494	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/28/2008
Diagnostic Test Group Clarity Ketone Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	05/19/2008
Diagnostic Test Group Clarity Urocheck 2 GP Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	05/19/2008
Diagnostic Test Group Clarity Urocheck 2 GP Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Protein	Urinalysis	05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Blood	Urinalysis	05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis
K061559	Urine Qualitative Dipstick Protein	Urinalysis	05/19/2008
Home Diagnostics, Preferred Plus Pharmacy TRUEread Blood Glucose Monitoring System
K042080	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/29/2008
AgaMatrix WaveSense KeyNote Pro Blood Glucose Monitoring System
K052762	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/24/2008
AgaMatrix WaveSense Presto Blood Glucose Monitoring System
K073573	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/24/2008
Target Corporation, EasyPRO Plus Blood Glucose Monitoring System
K063068	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/24/2008
Apex Biotechnology Corp. GlucoSure Voice Blood Glucose Monitoring System
K073137	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/18/2008
LifeScan One Touch UltraLink Blood Glucose Monitoring System
K073231	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/18/2008
Neuero Engineering Inc. 3test Supreme Glucose Monitoring System
K072905	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/18/2008
Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023639	Triglyceride	General Chemistry	04/14/2008
Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023640	HDL Cholesterol	General Chemistry	04/14/2008
Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023642	Cholesterol	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023642	Cholesterol	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023642	Cholesterol	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023639	Triglyceride	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023639	Triglyceride	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023640	HDL Cholesterol	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023640	HDL Cholesterol	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K955770	Gamma Glutamyl Transferase (GGT)	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K950164	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K950164	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K950164	Alkaline Phosphatase (ALP)	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K950164	Amylase	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K942782	Glucose	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K942782	Albumin	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K942782	Protein, Total	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K942782	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K942782	Bilirubin, Total	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagenr Disc} (Whole Blood)
K942782	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	04/14/2008
Apex Biotechnology Corp. GlucoSure Star Blood Glucose Monitoring System
K073648	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/14/2008
Tyson Bioresearch Inc. Diachex+ Determine Blood Glucose Monitoring System
K073492	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/14/2008
Tyson Bioresearch, Inc., Diachex+ Infinity Blood Glucose Monitoring System
K073492	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/14/2008
Diagnostic Test Group Clarity Strep A Rapid Test Strips
K983386	Streptococcus, Group A	Bacteriology	04/08/2008
Bayer A1CNow +  (For professional use)
K051321	Glycated Hemoglobin, Total	General Chemistry	03/31/2008
Fora Care Inc. Fora Comfort 2 in 1 Blood Glucose Plus Blood Pressure Monitoring System TD-3250
K062800	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/26/2008
HMD Biomedical Llc Evolution Blood Glucose Monitoring System
K072369	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/26/2008
Inverness Medical Professional Diagnostics BioStar Acceava hCG Urine II
K062361	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/26/2008
Tyson Bioresearch, Inc. EZ Scan Plus Blood Glucose Monitoring System
K072441	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/26/2008
Inverness Medical BioStar Acceava Strep A Twist {Strep A}
K023766	Streptococcus, Group A	Bacteriology	03/19/2008
Jant Pharmacal Accutest Integrated Strep A Rapid Test Device {Strep A}
K023766	Streptococcus, Group A	Bacteriology	03/19/2008
Moore Medical The Supply Experts Strep A Test - Cassette {Strep A}
K023766	Streptococcus, Group A	Bacteriology	03/19/2008
AmeriTek dBest One Step Occult Blood Test
K071242	Fecal Occult Blood	General Chemistry	03/12/2008
Diagnostic Devices Prodigy Voice Blood Glucose Monitoring System
K073118	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/12/2008
Diagnostic Test Group, Clarity Blood Glucose Monitoring System
K062829	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/12/2008
Bestgen Major III Blood Glucose Monitoring System
K072274	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/04/2008
Henry Schein One Step + Strep A Cassette Test
K023766	Streptococcus, Group A	Bacteriology	03/04/2008
TaiDoc Clever Chek TD-4232 Blood Glucose Monitoring System
K073119	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/04/2008
Qualigen, Inc. FastChek TSH  (Whole Blood)
K990658	Thyroid Stimulating Hormone (TSH)	Endocrinology	02/29/2008
Nova Biomedical Corp. StatStrip Glucose Hospital Meter
K060345	Glucose Monitoring Devices (Prescription Use Only)	General Chemistry	02/28/2008
Nova Biomedical, Nova Max Link Blood Glucose Monitoring System
K040603	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/28/2008
Henry Schein One Step + Mononucleosis Rapid Test Device  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	02/26/2008
Quidel QuickVue RSV Test
K061008	Respiratory Syncytial Virus	Virology	02/25/2008
Quidel QuickVue RSV Test
K070747	Respiratory Syncytial Virus	Virology	02/25/2008
Clarity MONO Mononucleosis Rapid Test  (Whole Blood)
K961024	Infectious Mononucleosis Antibodies (Mono)	General Immunology	02/13/2008
AgaMatrix WaveSense KeyNote Codeless Blood Glucose Monitoring System
K073573	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/31/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)
K063545	Amphetamines	Toxicology / TDM	01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)
K063545	Cannabinoids (THC)	Toxicology / TDM	01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)
K063545	Phencyclidine (PCP)	Toxicology / TDM	01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)
K063545	Cocaine Metabolites	Toxicology / TDM	01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)
K063545	Methadone	Toxicology / TDM	01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)
K063545	Methamphetamines	Toxicology / TDM	01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)
K063545	Benzodiazepines	Toxicology / TDM	01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)
K063545	Barbiturates	Toxicology / TDM	01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)
K063545	Morphine	Toxicology / TDM	01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)
K063545	Tricyclic Antidepressants	Toxicology / TDM	01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)
K063545	Amphetamines	Toxicology / TDM	01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)
K063545	Cannabinoids (THC)	Toxicology / TDM	01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)
K063545	Phencyclidine (PCP)	Toxicology / TDM	01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)
K063545	Cocaine Metabolites	Toxicology / TDM	01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)
K063545	Methadone	Toxicology / TDM	01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)
K063545	Methamphetamines	Toxicology / TDM	01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)
K063545	Benzodiazepines	Toxicology / TDM	01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)
K063545	Barbiturates	Toxicology / TDM	01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)
K063545	Morphine	Toxicology / TDM	01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)
K063545	Tricyclic Antidepressants	Toxicology / TDM	01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	01/30/2008
JANT Pharmacal Corporation Accutest Value + Urine Pregnancy Test Device
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/30/2008
Phamatech At Home 12 Drug Test (Model 9308T)
K070009	Amphetamines	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)
K070009	Cannabinoids (THC)	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)
K070009	Phencyclidine (PCP)	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)
K070009	Cocaine Metabolites	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)
K070009	Benzodiazepines	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)
K070009	Barbiturates	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)
K070009	Opiates	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)
K070009	Methadone	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)
K070009	Methamphetamines	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)
K070009	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)
K070009	Amphetamines	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)
K070009	Cannabinoids (THC)	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)
K070009	Phencyclidine (PCP)	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)
K070009	Cocaine Metabolites	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)
K070009	Opiates	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)
K070009	Methadone	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)
K070009	Methamphetamines	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)
K070009	Benzodiazepines	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)
K070009	Barbiturates	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)
K070009	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)
K070009	Oxycodone	Toxicology / TDM	01/23/2008
Phamatech At Home 12 Drug Test (Model 930T)
K070009	Oxycodone	Toxicology / TDM	01/23/2008
Becton Dickinson BD Chek Group A Strep Test
K010582	Streptococcus, Group A	Bacteriology	01/22/2008
Diagnostic Test Group Clarity H. pylori Rapid Test Device  (Whole Blood)
K980798	Helicobacter Pylori Antibodies	General Immunology	01/22/2008
BTNX Inc. Rapid Response H. pylori Whole Blood Rapid Test Device
K024360	Helicobacter Pylori Antibodies	General Immunology	01/15/2008
Abbott Diagnostics Signify ER Drug Screen Test
K041685	Amphetamines	Toxicology / TDM	01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test
K041685	Cannabinoids (THC)	Toxicology / TDM	01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test
K041685	Phencyclidine (PCP)	Toxicology / TDM	01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test
K041685	Cocaine Metabolites	Toxicology / TDM	01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test
K041685	Opiates	Toxicology / TDM	01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test
K041685	Propoxyphene	Toxicology / TDM	01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test
K041685	Benzodiazepines	Toxicology / TDM	01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test
K041685	Barbiturates	Toxicology / TDM	01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test
K041685	Tricyclic Antidepressants	Toxicology / TDM	01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test
K041685	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test
K041685	Oxycodone	Toxicology / TDM	01/08/2008
Accutech CholesTrak HDL Cholesterol Home Test
K072836	HDL Cholesterol	General Chemistry	01/08/2008
Diagnostic Devices, Inc. Prodigy Autocode Blood Glucose Monitoring System
K072784	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/08/2008
Jant Pharmacal Accutest Value + Mononucleosis Rapid Test  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	01/08/2008
Stanbio Rely Mono Rapid Test  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	01/08/2008
TaiDoc Technology Corporation Clever Chek TD-4227 Blood Glucose Monitoring System
K072784	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/08/2008
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {midstream} (OTC)
K071930	hCG, Urine	Endocrinology	12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {Cassette} (OTC)
K071930	hCG, Urine	Endocrinology	12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {strip} (OTC)
K071930	hCG, Urine	Endocrinology	12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {Cassette} (Professional Use)
K071930	hCG, Urine	Endocrinology	12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {midstream} (professional)
K071930	hCG, Urine	Endocrinology	12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {strip} (professional)
K071930	hCG, Urine	Endocrinology	12/19/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878	Amphetamines	Toxicology / TDM	12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878	Cannabinoids (THC)	Toxicology / TDM	12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878	Phencyclidine (PCP)	Toxicology / TDM	12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878	Cocaine Metabolites	Toxicology / TDM	12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878	Opiates	Toxicology / TDM	12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878	Methamphetamines	Toxicology / TDM	12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use)
K050878	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	12/13/2007
EPS Bio Technology EasyPlus mini Self Monitoring Blood Glucose System
K070053	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/06/2007
Gluco Perfect L.L.C., Gluco Perfect 2 Blood Glucose Monitoring System
K062799	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/06/2007
Jant Pharmacal Accutest Value + H. pylori Rapid Test Device  (Whole Blood)
K024350	Helicobacter Pylori Antibodies	General Immunology	11/26/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Ketone	Urinalysis	11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Bilirubin	Urinalysis	11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Glucose	Urinalysis	11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Nitrite	Urinalysis	11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Specific Gravity	Urinalysis	11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Blood	Urinalysis	11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Leukocytes	Urinalysis	11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Ph	Urinalysis	11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Protein	Urinalysis	11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Urobilinogen	Urinalysis	11/16/2007
JANT Pharmacal Corporation Accutest Value + Urine/Serum Pregnancy Test Device
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/16/2007
Vertex Diagnostics UltraTRAK Blood Glucose Monitoring System
K062235	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/16/2007
Macherey-Nagel URYXXON Relax
K061742	Urine Qualitative Dipstick Ketone	Urinalysis	11/08/2007
Macherey-Nagel URYXXON Relax
K061742	Urine Qualitative Dipstick Bilirubin	Urinalysis	11/08/2007
Macherey-Nagel URYXXON Relax
K061742	Urine Qualitative Dipstick Blood	Urinalysis	11/08/2007
Macherey-Nagel URYXXON Relax
K061742	Urine Qualitative Dipstick Glucose	Urinalysis	11/08/2007
Macherey-Nagel URYXXON Relax
K061742	Urine Qualitative Dipstick Leukocytes	Urinalysis	11/08/2007
Macherey-Nagel URYXXON Relax
K061742	Urine Qualitative Dipstick Ph	Urinalysis	11/08/2007
Macherey-Nagel URYXXON Relax
K061742	Urine Qualitative Dipstick Protein	Urinalysis	11/08/2007
Macherey-Nagel URYXXON Relax
K061742	Urine Qualitative Dipstick Specific Gravity	Urinalysis	11/08/2007
Macherey-Nagel URYXXON Relax
K061742	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	11/08/2007
Macherey-Nagel URYXXON Relax
K061742	Urine Qualitative Dipstick Nitrite	Urinalysis	11/08/2007
Macherey-Nagel URYXXON Relax
K061742	Urine Qualitative Dipstick Urobilinogen	Urinalysis	11/08/2007
BinaxNOW Influenza A & B Test  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens and Nasal Swabs (NS))
K062109	Influenza A/B	Virology	11/01/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K010670	chloride	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K010670	chloride	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole Blood)
K010670	chloride	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K992140	Potassium	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K992140	Carbon Dioxide, Total (CO2)	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K992140	Potassium	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K992140	Carbon Dioxide, Total (CO2)	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Reagent Disc} (Whole Blood)
K992140	Potassium	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Reagent Disc} (Whole Blood)
K992140	Carbon Dioxide, Total (CO2)	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Albumin	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Protein, Total	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Calcium, Total	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Glucose	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Sodium	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Creatinine	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Alkaline Phosphatase (ALP)	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Urea (BUN)	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Bilirubin, Total	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211	Calcium, Total	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211	Glucose	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211	Sodium	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211	Creatinine	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211	Urea (BUN)	General Chemistry	10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole Blood)
K993211	Sodium	General Chemistry	10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Protein, Total	General Chemistry	10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Calcium, Total	General Chemistry	10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Creatinine	General Chemistry	10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Urea (BUN)	General Chemistry	10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211	Calcium, Total	General Chemistry	10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211	Creatinine	General Chemistry	10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211	Urea (BUN)	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Albumin	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Glucose	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Sodium	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Alkaline Phosphatase (ALP)	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211	Bilirubin, Total	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211	Glucose	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211	Sodium	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole Blood)
K993211	Sodium	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K992140	Carbon Dioxide, Total (CO2)	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc,} (Whole Blood)
K992140	Potassium	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K992140	Carbon Dioxide, Total (CO2)	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Reagent Disc} (Whole Blood)
K992140	Potassium	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Reagent Disc} (Whole Blood)
K992140	Carbon Dioxide, Total (CO2)	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc,} (Whole Blood)
K992140	Potassium	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K010670	chloride	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K010670	chloride	General Chemistry	10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole Blood)
K010670	chloride	General Chemistry	10/30/2007
Gluco Perfect, L.L.C. Gluco Perfect Blood Glucose Monitoring System
K032029	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/30/2007
QuantRx Biomedical QuantRx Female Fertility Test
K070484	Follicle Stimulating Hormone (FSH)	Endocrinology	10/29/2007
PSS World Medical Select Diagnostics hCG Dipstick
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/25/2007
Heritage House '76 Inc., The Precious Feet Premium Pregnancy Test
K050741	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/24/2007
Abbott Diabetes Care Inc. Precision Xceed Pro Glucose Monitoring System
K022941	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/22/2007
Clearview COMPLETE HIV 1/2  (Fingerstick Veinipuncture, whole blood, )
BP050009	HIV-1 and HIV-2 Antibodies	General Immunology	10/22/2007
Abaxis Piccolo xpress Chemistry Analyzer {Kidney Check Panel} (Whole Blood)
K942782	Creatinine	General Chemistry	10/18/2007
Abaxis Piccolo xpress Chemistry Analyzer {Kidney Check Panel} (Whole Blood)
K942782	Urea (BUN)	General Chemistry	10/18/2007
ACON Laboratories UTI Urinary Tract Infection Test Strips
K063295	Nitrite, Urine	General Chemistry	10/15/2007
ACON Laboratories UTI Urinary Tract Infection Test Strips
K063295	Leukocyte Esterase, Urinary	Urinalysis	10/15/2007
Duramed Pharmaceuticals, Inc. AmniScreen Home Detection Liner Kit
K071100	Vaginal pH	General Chemistry	10/15/2007
Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL Panel Test Strips}
K071593	Cholesterol	General Chemistry	10/15/2007
Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL Panel Test Strips}
K071593	HDL Cholesterol	General Chemistry	10/15/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Panel Test Strips}
K071593	HDL Cholesterol	General Chemistry	10/15/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Panel Test Strips}
K071593	Cholesterol	General Chemistry	10/15/2007
Tyson Bioresearch, Inc. Ultimate EZ Smart Plus Blood Glucose Monitoring System
K052818	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/15/2007
Lifescan, Inc. OneTouch Select Meter
K072543	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/11/2007
Siemens Medical Diagnostics DCA Vantage Analyzer
K071466	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	10/11/2007
BTNX Inc. Clarity Fecal Occult Blood (FOB) Self Test
K070660	Fecal Occult Blood	General Chemistry	10/05/2007
BTNX Inc. Know Fecal Occult Blood (FOB) Self Test
K070660	Fecal Occult Blood	General Chemistry	10/05/2007
BTNX Inc. Rapid Response Fecal Occult Blood (FOB) Self Test
K070660	Fecal Occult Blood	General Chemistry	10/05/2007
TaiDoc Advocate Redi-Code Blood Glucose Monitoring System
K072039	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/04/2007
AgaMatrix WaveSense Jazz Blood Glucose Monitoring System
K072413	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/02/2007
Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood)
K053110	Hemoglobin	Hematology	09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood)
K053110	Glucose	General Chemistry	09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood)
K053110	Sodium	General Chemistry	09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood)
K053110	Potassium	General Chemistry	09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood)
K053110	Calcium, Ionized	General Chemistry	09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood)
K053110	Creatinine	General Chemistry	09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood)
K053110	Urea (BUN)	General Chemistry	09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood)
K053110	chloride	General Chemistry	09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood)
K053110	Carbon Dioxide, Total (CO2)	General Chemistry	09/21/2007
Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood)
K053110	Hematocrit	Hematology	09/21/2007
Abbott Laboratories Signify hCG Urine Dipstick
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/21/2007
Moore Medical The Supply Experts hCG Urine -Dipstick
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/21/2007
Moore Medical The Supply Experts hCG Urine-Cassette
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/21/2007
Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips}
K071507	HDL Cholesterol	General Chemistry	09/21/2007
Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips}
K071507	Glucose	General Chemistry	09/21/2007
Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips}
K071507	Cholesterol	General Chemistry	09/21/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips}
K071507	Glucose	General Chemistry	09/21/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips}
K071507	Cholesterol	General Chemistry	09/21/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips}
K071507	HDL Cholesterol	General Chemistry	09/21/2007
TaiDoc REVOLUTION TD-4229 Blood Glucose Monitoring System
K072489	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/21/2007
US Diagnostics, Inc. Maxima Blood Glucose Monitoring System
K051651	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/20/2007
Polymedco Poly Stat Strep A Dipstick
K010582	Streptococcus, Group A	Bacteriology	09/18/2007
Abbott Laboratories Signify H. pylori Cassette  (Whole Blood)
K024350	Helicobacter Pylori Antibodies	General Immunology	09/11/2007
AI DE Diagnostic Co. One Step HCG Serum/Urine Combo Pregnancy Test (Cassette Style)
K062703	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/11/2007
AI DE Diagnostic Co. One Step HCG Serum/Urine Combo Pregnancy Test (Strip Style)
K062703	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/11/2007
AI DE Diagnostic Co. One Step HCG Urine Pregnancy Test (Cassette Style)
K062703	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/11/2007
AI DE Diagnostic Co. One Step HCG Urine Pregnancy Test (Midstream)
K062703	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/11/2007
AI DE Diagnostic Co. One Step HCG Urine Pregnancy Test (Strip Style)
K062703	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/11/2007
Inverness Medical Professional Diagnostics Clearview 25 hCG Combo
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/24/2007
Inverness Medical Professional Diagnostics Signify hCG Combo Cassette
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/24/2007
Moore Medical The Supply Experts hCG Serum/Urine Test-Cassette
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/24/2007
Polymedco, Inc. Poly stat hCG Test (Urine/Serum)
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/24/2007
Abbott Laboratories Signify Strep A Dipstick
K010582	Streptococcus, Group A	Bacteriology	08/21/2007
Jant Pharmacal Accustrip Strep A Value+ Test Strip
K010582	Streptococcus, Group A	Bacteriology	08/21/2007
JANT Pharmacal Corp. Accustrip Value+ hCG One Step Pregnancy Test Strip (Urine)
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/17/2007
Henry Schein, Inc. One Step + hCG Combo Test
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/16/2007
Henry Schein, Inc. One Step + hCG Urine Cassette Test
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/16/2007
Henry Schein, Inc. One Step + hCG Urine Strip Test
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/16/2007
Lightstar Enterprises, Inc. GlucoTest Excel Blood Glucose Monitoring System
K043512	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/16/2007
Moore Medical The Supply Experts Strep A Rapid Test - Dipstick
K010582	Streptococcus, Group A	Bacteriology	08/14/2007
Arkray GLUCOCARD X-METER Blood Glucose Monitoring System
K063771	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/09/2007
Physicians Medical Supply Quick Chek ultra Blood Glucose Monitoring System
K062235	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/09/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878	Amphetamines	Toxicology / TDM	08/07/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878	Cannabinoids (THC)	Toxicology / TDM	08/07/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878	Phencyclidine (PCP)	Toxicology / TDM	08/07/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878	Cocaine Metabolites	Toxicology / TDM	08/07/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878	Opiates	Toxicology / TDM	08/07/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878	Methamphetamines	Toxicology / TDM	08/07/2007
Jant Pharmacal Accutest SplitCup  (Professional Use)
K050878	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	08/07/2007
AgaMatrix Jazz Blood Glucose Monitoring System
K071393	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/27/2007
Exir Pharmaceutical Maximed Exichek TD-4224 Blood Glucose Monitoring System
K070239	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/27/2007
Henry Schein One Step + H. Pylori Rapid Test Device {Whole Blood} (H. Pylori)
K024350	Helicobacter Pylori Antibodies	General Immunology	07/25/2007
Polymedco Poly Stat H. Pylori Test {Whole Blood} (H. Pylori)
K024350	Helicobacter Pylori Antibodies	General Immunology	07/25/2007
Cardinal Health SP Brand Rapid Test hCG Combo
K062361	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/12/2007
Clearview MONO Whole Blood  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	07/12/2007
HENRY SCHEIN ONE STEP+ MONO TEST  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	07/12/2007
Inverness Medical Clearview hCG Combo II
K062361	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/12/2007
Poly Stat Mono Test  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	07/12/2007
PSS World Medical Select Diagnostics hCG Combo Cassette
K062361	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/12/2007
PSS World Medical Select Diagnostics hCG Urine Cassette
K062361	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/12/2007
Signify Mono Cassette  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	07/12/2007
Home Diagnostics, facil TRUEread Blood Glucose Monitoring System
K042080	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/03/2007
Home Diagnostics, Good Neighbor Pharmacy TRUEread Blood Glucose Monitoring System
K042080	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/03/2007
Home Diagnostics, Invacare TRUEread Blood Glucose Monitoring System
K042080	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/03/2007
Home Diagnostics, Leader TRUEread Blood Glucose Monitoring System
K042080	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/03/2007
Home Diagnostics, sunmark TRUEread Blood Glucose Monitoring System
K042080	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/03/2007
Applied DNA Technologies Bionexia hCG Pregnancy Cassette and Dipstick Tests
K070921	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/02/2007
Bionexia hCG Pregnancy Serum/Urine Cassette and Dipstick Tests
K071030	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/02/2007
Select Diagnostics Rapid Test Mono Cassette  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	07/02/2007
Visgeneer, Inc. eBsensor Blood Glucose Monitoring System
K062555	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/02/2007
Alfa Scientific Designs Fecal Occult Blood (FOB) Self-Test
K070660	Fecal Occult Blood	General Chemistry	06/28/2007
Alfa Scientific Designs Instant-View Fecal Occult Blood (FOB) Self-Test  (Cassette)
K070660	Fecal Occult Blood	General Chemistry	06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant Verdict Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant View Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test
K063545	Amphetamines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test
K063545	Cannabinoids (THC)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test
K063545	Cocaine Metabolites	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test
K063545	Methadone	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test
K063545	Benzodiazepines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test
K063545	Barbiturates	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test
K063545	Morphine	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-Verdict Multi-Drug of Abuse Urine Cup Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test
K063545	Amphetamines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test
K063545	Cannabinoids (THC)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test
K063545	Cocaine Metabolites	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test
K063545	Methadone	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test
K063545	Benzodiazepines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test
K063545	Barbiturates	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test
K063545	Morphine	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Cup Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test
K063545	Amphetamines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test
K063545	Cannabinoids (THC)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test
K063545	Cocaine Metabolites	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test
K063545	Methadone	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test
K063545	Methamphetamines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test
K063545	Benzodiazepines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test
K063545	Barbiturates	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test
K063545	Morphine	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Cup Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test
K063545	Amphetamines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test
K063545	Cannabinoids (THC)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test
K063545	Phencyclidine (PCP)	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test
K063545	Cocaine Metabolites	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test
K063545	Methadone	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test
K063545	Methamphetamines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test
K063545	Benzodiazepines	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test
K063545	Morphine	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test
K063545	Tricyclic Antidepressants	Toxicology / TDM	06/28/2007
Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test
K063545	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	06/28/2007
Arkray, PocketChem EZ Blood Glucose Monitoring System
K063068	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/28/2007
Cardinal Health SP Brand Rapid Test hCG Cassette
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/28/2007
Cardinal Health SP Brand Rapid Test hCG Combo Cassette
K062361	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/28/2007
Cardinal Health SP Brand Rapid Test hCG Dipstick
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device
K050050	Amphetamines	Toxicology / TDM	06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device
K050050	Cannabinoids (THC)	Toxicology / TDM	06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device
K050050	Phencyclidine (PCP)	Toxicology / TDM	06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device
K050050	Cocaine Metabolites	Toxicology / TDM	06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device
K050050	Opiates	Toxicology / TDM	06/28/2007
eScreen, Inc. mCheck Multi-Line Screen Test Device
K050050	Methamphetamines	Toxicology / TDM	06/28/2007
Physicians Medical Supply Quick Chek Blood Glucose Monitoring System
K063212	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/28/2007
PSS World Medical Select Diagnostics Strep A Twist
K023766	Streptococcus, Group A	Bacteriology	06/28/2007
Tyson Bioresearch, Inc. EZ Smart-608 Blood Glucose Monitoring System
K062829	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/28/2007
Cambridge Sensors ltd. microdot Blood Glucose Monitoring System
K070524	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/25/2007
Kurkel Enterprises Early-Pregnancy-Tests.com Ovulation Midstream Tests
X050002	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	06/25/2007
Kurkel Enterprises Early-Pregnancy-Tests.com Ovulation Test Strips
X050002	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	06/25/2007
PSS World Medical Select Diagnostics Strep A Dipstick
K010582	Streptococcus, Group A	Bacteriology	06/25/2007
Rush Industries Ovulation Test
X050002	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	06/25/2007
Select Medical Products Brand Rapid Test H. Pylori {Whole Blood Only} (H. Pylori)
K024350	Helicobacter Pylori Antibodies	General Immunology	06/25/2007
Fertell Male Fertility Test
K041039	Semen	Hematology	06/18/2007
Nova Biomedical Nova Max Blood Glucose Monitoring System
K070255	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/18/2007
Fisher Healthcare Sure-Vue H. pylori Test  (Whole Blood)
K024350	Helicobacter Pylori Antibodies	General Immunology	06/11/2007
Inverness Medical Profesional Diagnostics Signify H. pylori Test  (Whole Blood)
K024350	Helicobacter Pylori Antibodies	General Immunology	06/11/2007
McKesson Medi-Lab Performance H. pylori Test  (Whole Blood)
K024350	Helicobacter Pylori Antibodies	General Immunology	06/11/2007
Savyon Diagnostics Uriscreen {Bacteriuria}
K882211	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	06/11/2007
PSS World Medical Select hCG Cassette
K041728	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/01/2007
PSS World Medical Select hCG Combo
K041728	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/01/2007
PSS World Medical Select hCG Dipstick
K041728	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/01/2007
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K050652	Creatinine	General Chemistry	05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K053401	Protein, Total	General Chemistry	05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood)
K053401	Albumin	General Chemistry	05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood)
K053401	Calcium, Total	General Chemistry	05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood)
K053401	Glucose	General Chemistry	05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood)
K053401	Creatinine	General Chemistry	05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood)
K053401	Urea (BUN)	General Chemistry	05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood)
K053401	Protein, Total	General Chemistry	05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood)
K053401	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood)
K053401	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood)
K053401	Alkaline Phosphatase (ALP)	General Chemistry	05/31/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood)
K053401	Bilirubin, Total	General Chemistry	05/31/2007
Cardinal Health, SP Brand Rapid Test Mono  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	05/31/2007
Roche Diagnostics Corp. ACCU-CHEK Performa System
K070585	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/31/2007
SA Scientific SAS Pregnancy Serum/Urine Test
K010593	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/31/2007
Cardinal Health SP Brand Rapid Test H. Pylori {H. Pylori} (Whole Blood)
K024350	Helicobacter Pylori Antibodies	General Immunology	05/24/2007
Cardinal Health SP Brand Rapid Test Strep A Dipstick
K010582	Streptococcus, Group A	Bacteriology	05/24/2007
Innovacon Multi-Clin Drug Screen Test Device
K041685	Amphetamines	Toxicology / TDM	05/24/2007
Innovacon Multi-Clin Drug Screen Test Device
K041685	Cannabinoids (THC)	Toxicology / TDM	05/24/2007
Innovacon Multi-Clin Drug Screen Test Device
K041685	Phencyclidine (PCP)	Toxicology / TDM	05/24/2007
Innovacon Multi-Clin Drug Screen Test Device
K041685	Cocaine Metabolites	Toxicology / TDM	05/24/2007
Innovacon Multi-Clin Drug Screen Test Device
K041685	Opiates	Toxicology / TDM	05/24/2007
Innovacon Multi-Clin Drug Screen Test Device
K041685	Propoxyphene	Toxicology / TDM	05/24/2007
Innovacon Multi-Clin Drug Screen Test Device
K041685	Benzodiazepines	Toxicology / TDM	05/24/2007
Innovacon Multi-Clin Drug Screen Test Device
K041685	Barbiturates	Toxicology / TDM	05/24/2007
Innovacon Multi-Clin Drug Screen Test Device
K041685	Tricyclic Antidepressants	Toxicology / TDM	05/24/2007
Innovacon Multi-Clin Drug Screen Test Device
K041685	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/24/2007
Innovacon Multi-Clin Drug Screen Test Device
K041685	Oxycodone	Toxicology / TDM	05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
K041685	Amphetamines	Toxicology / TDM	05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
K041685	Cannabinoids (THC)	Toxicology / TDM	05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
K041685	Phencyclidine (PCP)	Toxicology / TDM	05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
K041685	Cocaine Metabolites	Toxicology / TDM	05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
K041685	Opiates	Toxicology / TDM	05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
K041685	Propoxyphene	Toxicology / TDM	05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
K041685	Benzodiazepines	Toxicology / TDM	05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
K041685	Barbiturates	Toxicology / TDM	05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
K041685	Tricyclic Antidepressants	Toxicology / TDM	05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
K041685	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/24/2007
Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
K041685	Oxycodone	Toxicology / TDM	05/24/2007
Immuno Detector Mono {Whole Blood}
K961024	Infectious Mononucleosis Antibodies (Mono)	General Immunology	05/17/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood)
K922612	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	05/16/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood)
K922612	Triglyceride	General Chemistry	05/16/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood)
K922612	HDL Cholesterol	General Chemistry	05/16/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood)
K922612	Cholesterol	General Chemistry	05/16/2007
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test
K063693	Fecal Occult Blood	General Chemistry	05/16/2007
Immunostics Detector H. pylori WB {H. pylori Antiboby Test} (For whole blood)
K980798	Helicobacter Pylori Antibodies	General Immunology	05/16/2007
KoreaMedico Chextic
K062096	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/10/2007
McKesson Medi-Lab Performance Strep A Test - Twist
K023766	Streptococcus, Group A	Bacteriology	05/10/2007
PerMaxim RediScreen Strep A Twist Cassette
K023766	Streptococcus, Group A	Bacteriology	05/10/2007
AmeriTek USA, dBest One Step hCG Panel Test Kit
K061257	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/07/2007
Church & Dwight Co., Inc. FIRST RESPONSE Gold Digital Pregnancy Test
K070054	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/07/2007
Diacare Corp. EASY CHECK Blood Glucose Monitoring System
K062538	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/02/2007
Taidoc Technology easi check precise Blood Glucose Monitoring System
K042005	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/02/2007
Abbott Diabetes Care Inc., FreeStyle Lite Glucose Monitoring System
K070850	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/12/2007
BTNX Inc. Rapid Response Blood Glucose Monitoring System
K051854	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/12/2007
Clearview MONO Whole Blood  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	04/12/2007
Diabetic Supply of Suncoast, Inc. Advocate Duo Blood Glucose Plus Blood Pressure Monitoring System
K070641	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/12/2007
HemoCue Hb 301 System
K061047	Hemoglobin	Hematology	04/12/2007
Medi-Lab Performance Infectious Mononucleosis Test  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	04/12/2007
Signify Mono Whole Blood  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	04/12/2007
Fisher HealthCare Sure-Vue Serum/Urine hCG-STAT
K062361	hCG, Urine	Endocrinology	04/02/2007
Jant Pharmacal Corporation Accutest TSH  (Whole Blood)
K990658	Thyroid Stimulating Hormone (TSH)	Endocrinology	04/02/2007
Bionime Corporation Rightest Blood Glucose Monitoring System
K062567	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/29/2007
Fisher HealthCare Sure-Vue Urine hCG
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/29/2007
Redwood Toxicology Laboratory Reditest Home Drug Test
K050878	Amphetamines	Toxicology / TDM	03/29/2007
Redwood Toxicology Laboratory Reditest Home Drug Test
K050878	Cannabinoids (THC)	Toxicology / TDM	03/29/2007
Redwood Toxicology Laboratory Reditest Home Drug Test
K050878	Phencyclidine (PCP)	Toxicology / TDM	03/29/2007
Redwood Toxicology Laboratory Reditest Home Drug Test
K050878	Cocaine Metabolites	Toxicology / TDM	03/29/2007
Redwood Toxicology Laboratory Reditest Home Drug Test
K050878	Opiates	Toxicology / TDM	03/29/2007
Redwood Toxicology Laboratory Reditest Home Drug Test
K050878	Methamphetamines	Toxicology / TDM	03/29/2007
Redwood Toxicology Laboratory Reditest Home Drug Test
K050878	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	03/29/2007
Fisher HealthCare Sure-Vue Serum/Urine hCG
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/28/2007
Fisher HealthCare Sure-Vue Strep A Test
K010582	Streptococcus, Group A	Bacteriology	03/28/2007
Home Diagnostics, TRUEread Blood Glucose Monitoring System
K042080	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/28/2007
Mckesson Medi-Lab Strep A Test - Dipstick
K010582	Streptococcus, Group A	Bacteriology	03/28/2007
McKesson Medical-Surgical Medi-Lab Performance hCG Combo Test-Cassette
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/28/2007
SA Scientific SAS Pregnancy Urine Test
K010522	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/28/2007
Roche Diagnostics CoaguChek XS
K060978	Prothrombin Time (PT)	Hematology	03/23/2007
Kurkel Enterprises Early-Pregnancy-Tests.com Pregnancy Midstream Tests
K974059	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/19/2007
Kurkel Enterprises Early-Pregnancy-Tests.com Pregnancy Test Strips
K951705	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/19/2007
Rush Industries Rush Pregnancy Test
K974059	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/19/2007
TaiDoc Clever Chek Blood Glucose Monitoring System TD-4230
K070472	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/19/2007
TaiDoc SureChek Blood Glucose Monitoring System
K070472	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/19/2007
Bayer Clinitek Status Urine Chemistry Analyzer
K032563	hCG, Urine	Endocrinology	03/16/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K950164	Calcium, Total	General Chemistry	03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K934592	Uric Acid	General Chemistry	03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Albumin	General Chemistry	03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Protein, Total	General Chemistry	03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Glucose	General Chemistry	03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Creatinine	General Chemistry	03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Urea (BUN)	General Chemistry	03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Bilirubin, Total	General Chemistry	03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood)
K942782	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood)
K942782	Glucose	General Chemistry	03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood)
K942782	Creatinine	General Chemistry	03/14/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood)
K942782	Urea (BUN)	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood)
K942782	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood)
K942782	Glucose	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood)
K942782	Creatinine	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood)
K942782	Urea (BUN)	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Albumin	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Protein, Total	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Glucose	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Creatinine	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Urea (BUN)	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K942782	Bilirubin, Total	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K934592	Uric Acid	General Chemistry	03/14/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K950164	Calcium, Total	General Chemistry	03/14/2007
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (Professional Use)
K050050	Amphetamines	Toxicology / TDM	03/14/2007
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (Professional Use)
K050050	Cannabinoids (THC)	Toxicology / TDM	03/14/2007
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (Professional Use)
K050050	Phencyclidine (PCP)	Toxicology / TDM	03/14/2007
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (Professional Use)
K050050	Cocaine Metabolites	Toxicology / TDM	03/14/2007
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (Professional Use)
K050050	Opiates	Toxicology / TDM	03/14/2007
Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (Professional Use)
K050050	Methamphetamines	Toxicology / TDM	03/14/2007
SA Scientific SAS Pregnancy Serum/Urine Test
K010593	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/14/2007
Fisher HealthCare Sure-Vue Urine hCG Strip
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/07/2007
Innovacon FOB Flipcard Fecal Occult Blood Test
K063673	Fecal Occult Blood	General Chemistry	03/07/2007
McKesson Medical-Surgical, Medi-Lab Performance hCG Urine Test - Cassette
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/07/2007
McKesson Medical-Surgical, Medi-Lab Performance hCG Urine Test - Dipstick
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/07/2007
Tyson Bioresearch, Inc. SMARTCHEX Blood Glucose Monitoring System
K052818	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/07/2007
Roche Diagnostics Accu-Chek Inform System  (Professional Use)
K003846	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/26/2007
Roche Diagnostics CoaguChek XS PST
K062925	Prothrombin Time (PT)	Hematology	02/26/2007
Apex Biotechnology Corp. Assure 4 Blood Glucose Monitoring System
K070088	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/22/2007
Innovacon Integrated E-Z Split Key Cup II  (Professional Use)
K050878	Amphetamines	Toxicology / TDM	02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (Professional Use)
K050878	Cannabinoids (THC)	Toxicology / TDM	02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (Professional Use)
K050878	Phencyclidine (PCP)	Toxicology / TDM	02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (Professional Use)
K050878	Cocaine Metabolites	Toxicology / TDM	02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (Professional Use)
K050878	Opiates	Toxicology / TDM	02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (Professional Use)
K050878	Methamphetamines	Toxicology / TDM	02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (Professional Use)
K050878	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	02/22/2007
Inverness Medical Professional Devices Clearview hCG Urine Cassette
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/13/2007
Inverness Medical Professional Diagnostics Clearview hCG Combo II
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/13/2007
Inverness Medical Professional Diagnostics Clearview hCG Urine Dipstick
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/13/2007
Inverness Medical Professional Diagnostics Signify hCG Combo Urine/Serum
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/13/2007
Inverness Medical Professional Diagnostics Signify hCG Urine Cassette
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/13/2007
Inverness Medical Professional Diagnostics Signify hCG Urine Dipstick
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/13/2007
Ok Biotech Co., Ltd. Ok Meter Blood Glucose Monitoring System
K063026	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/13/2007
Inverness Medical Clearview Strep A Exact II Dipstick
K010582	Streptococcus, Group A	Bacteriology	02/08/2007
Select Diagnostics Immunochemical Fecal Occult Blood Test
K060463	Fecal Occult Blood	General Chemistry	02/08/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis
K023885	Urine Qualitative Dipstick Ketone	Urinalysis	02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis
K023885	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis
K023885	Urine Qualitative Dipstick Blood	Urinalysis	02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis
K023885	Urine Qualitative Dipstick Glucose	Urinalysis	02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis
K023885	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis
K023885	Urine Qualitative Dipstick Nitrite	Urinalysis	02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis
K023885	Urine Qualitative Dipstick Ph	Urinalysis	02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis
K023885	Urine Qualitative Dipstick Protein	Urinalysis	02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis
K023885	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis
K023885	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis
K023885	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	02/07/2007
Inverness Medical Clearview H. pylori Test  (Whole Blood)
K024350	Helicobacter Pylori Antibodies	General Immunology	02/07/2007
Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}
K070017	Triglyceride	General Chemistry	02/07/2007
Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}
K070017	HDL Cholesterol	General Chemistry	02/07/2007
Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}
K070017	Glucose	General Chemistry	02/07/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}
K070017	Triglyceride	General Chemistry	02/07/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}
K070017	HDL Cholesterol	General Chemistry	02/07/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}
K070017	Glucose	General Chemistry	02/07/2007
Apex Biotechnology Corp. Gluco Track Blood Glucose Monitoring System
K062799	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/05/2007
TaiDoc Advocate Blood Glucose Monitoring System
K063212	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/31/2007
Teco Diagnostics Microalbumin 2-1 Combo Strip
K061419	Urine Qualitative Dipstick Protein	Urinalysis	01/29/2007
Teco Diagnostics Microalbumin 2-1 Combo Strip
K061419	Urine Qualitative Dipstick Creatinine	Urinalysis	01/29/2007
EUKARE Blood Glucose Monitoring System
K062892	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/26/2007
InSure Quik Fecal Immunochemical Test (F.I.T.)
K060930	Fecal Occult Blood	General Chemistry	01/26/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K950164	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	01/22/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K950164	Alkaline Phosphatase (ALP)	General Chemistry	01/22/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K950164	Amylase	General Chemistry	01/22/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood)
K950164	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	01/22/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood)
K955770	Gamma Glutamyl Transferase (GGT)	General Chemistry	01/22/2007
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K955770	Gamma Glutamyl Transferase (GGT)	General Chemistry	01/22/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K955770	Gamma Glutamyl Transferase (GGT)	General Chemistry	01/22/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood)
K955770	Gamma Glutamyl Transferase (GGT)	General Chemistry	01/22/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood)
K950164	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	01/22/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K950164	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	01/22/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K950164	Alkaline Phosphatase (ALP)	General Chemistry	01/22/2007
Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K950164	Amylase	General Chemistry	01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K950164	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K950164	Alkaline Phosphatase (ALP)	General Chemistry	01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K950164	Amylase	General Chemistry	01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K942782	Albumin	General Chemistry	01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K942782	Protein, Total	General Chemistry	01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K942782	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K942782	Glucose	General Chemistry	01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K942782	Bilirubin, Total	General Chemistry	01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K955770	Gamma Glutamyl Transferase (GGT)	General Chemistry	01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K023640	HDL Cholesterol	General Chemistry	01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K023642	Cholesterol	General Chemistry	01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K023639	Triglyceride	General Chemistry	01/22/2007
Taidoc Technology Corporation Clever Chek TD-3213 Blood Glucose Plus Blood Pressure Monitoring System
K062800	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/18/2007
Taidoc Technology Corporation Clever Chek TD-3215 Blood Glucose Plus Blood Pressure Monitoring System
K062800	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/18/2007
Taidoc Technology Corporation Clever Chek TD-3217 Blood Glucose Plus Blood Pressure Monitoring System
K062800	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/18/2007
Taidoc Technology Corporation Clever Chek TD-3250 Blood Glucose Plus Blood Pressure Monitoring System
K062800	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/18/2007
Taidoc Technology Corporation Dr. T TD-3216 Blood Glucose Plus Blood Pressure Monitoring System
K062800	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/18/2007
US Diagnostics, Inc. EASYGLUCO Glucose Monitoring System
K061431	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/18/2007
Natureplex, LLC BE CERTAIN Home Pregnancy Test
K051963	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/12/2007
Arkray, Ferrara Blood Glucose Monitoring System
K063068	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/09/2007
Common Sense Ltd. Fem-V Test Kit
K043109	Vaginal pH	General Chemistry	01/09/2007
Henry Schein Urispec 4-Way Reagent Test Strips
K991927	Urine Qualitative Dipstick Glucose	Urinalysis	01/09/2007
Henry Schein Urispec 4-Way Reagent Test Strips
K991927	Urine Qualitative Dipstick Leukocytes	Urinalysis	01/09/2007
Henry Schein Urispec 4-Way Reagent Test Strips
K991927	Urine Qualitative Dipstick Nitrite	Urinalysis	01/09/2007
Henry Schein Urispec 4-Way Reagent Test Strips
K991927	Urine Qualitative Dipstick Protein	Urinalysis	01/09/2007
LifeSign, LLC Status hCG Strip
K950307	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/09/2007
ARJ Medical URITEST 10 Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Ketone	Urinalysis	12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Bilirubin	Urinalysis	12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Blood	Urinalysis	12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Glucose	Urinalysis	12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Leukocytes	Urinalysis	12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Nitrite	Urinalysis	12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Ph	Urinalysis	12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Protein	Urinalysis	12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Urobilinogen	Urinalysis	12/30/2006
ARJ Medical URITEST 10 Reagent Strips for Urinalysis
K052719	Urine Qualitative Dipstick Specific Gravity	Urinalysis	12/30/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup
K050878	Amphetamines	Toxicology / TDM	12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup
K050878	Cannabinoids (THC)	Toxicology / TDM	12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup
K050878	Phencyclidine (PCP)	Toxicology / TDM	12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup
K050878	Cocaine Metabolites	Toxicology / TDM	12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup
K050878	Opiates	Toxicology / TDM	12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup
K050878	Methamphetamines	Toxicology / TDM	12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup
K050878	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup
K050878	Amphetamines	Toxicology / TDM	12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup
K050878	Cannabinoids (THC)	Toxicology / TDM	12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup
K050878	Phencyclidine (PCP)	Toxicology / TDM	12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup
K050878	Cocaine Metabolites	Toxicology / TDM	12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup
K050878	Opiates	Toxicology / TDM	12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup
K050878	Methamphetamines	Toxicology / TDM	12/28/2006
Wolfe Drug Testing RealityCheck Integrated Specimen Cup
K050878	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	12/28/2006
Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole Blood)
K042443	Triglyceride	General Chemistry	12/12/2006
Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole Blood)
K042443	HDL Cholesterol	General Chemistry	12/12/2006
Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole Blood)
K042443	Cholesterol	General Chemistry	12/12/2006
Taidoc Clever Chek Blood Glucose Monitoring System TD-4223
K063212	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/29/2006
Taidoc Clever Chek Blood Glucose Monitoring System TD-4231
K063212	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/29/2006
Bayer Diagnostics Ascencia BREEZE 2 Blood Glucose Monitoring System
K062347	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/22/2006
LifeSign Status Mono  (For whole blood)
K961024	Infectious Mononucleosis Antibodies (Mono)	General Immunology	11/22/2006
All Medicus GlucoDr SuperSensor Blood Glucose Test System
K050985	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/20/2006
Chembio HIV 1/2 STAT-PAK Assay  (Fingerstick, Venipuncture Whole Blood)
BP050010	HIV Antibodies	General Immunology	11/20/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K023489	Amphetamines	Toxicology / TDM	11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K023489	Cannabinoids (THC)	Toxicology / TDM	11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K023489	Phencyclidine (PCP)	Toxicology / TDM	11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K023489	Cocaine Metabolites	Toxicology / TDM	11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K023489	Opiates	Toxicology / TDM	11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K023489	Methadone	Toxicology / TDM	11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K023489	Methamphetamines	Toxicology / TDM	11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K023489	Benzodiazepines	Toxicology / TDM	11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K023489	Barbiturates	Toxicology / TDM	11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K023489	Tricyclic Antidepressants	Toxicology / TDM	11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K023489	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	11/14/2006
Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K023489	Oxycodone	Toxicology / TDM	11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K022355	Amphetamines	Toxicology / TDM	11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K022355	Cannabinoids (THC)	Toxicology / TDM	11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K022355	Phencyclidine (PCP)	Toxicology / TDM	11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K022355	Cocaine Metabolites	Toxicology / TDM	11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K022355	Opiates	Toxicology / TDM	11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K022355	Methadone	Toxicology / TDM	11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K022355	Methamphetamines	Toxicology / TDM	11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K022355	Benzodiazepines	Toxicology / TDM	11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K022355	Barbiturates	Toxicology / TDM	11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K022355	Tricyclic Antidepressants	Toxicology / TDM	11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K022355	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	11/14/2006
Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)
K022355	Oxycodone	Toxicology / TDM	11/14/2006
Inverness Medical - BioStar Inc. Acceava hCG Basic II
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/14/2006
Planned Parenthood hCG Pregnancy Test Dipstick
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/14/2006
Planned Parenthood hCG Pregnancy Test One Step Cassette
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/14/2006
Bayer Clinitek Status Urine Chemistry Analyzer
K031947	Microalbumin	General Chemistry	11/01/2006
BioStar Acceava Mono II  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	11/01/2006
BTNX Inc Rapid Response H. pylori Rapid Test Device  (Whole Blood)
K024350	Helicobacter Pylori Antibodies	General Immunology	11/01/2006
GlucoPlus Inc. GlucoPlus Blood Glucose Monitoring System
K061234	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/01/2006
Innovacon hCG Ultra Test Device
K062361	hCG, Urine	Endocrinology	11/01/2006
Inverness Medical BioStar Acceava Strep A Test
K010582	Streptococcus, Group A	Bacteriology	11/01/2006
BTNX Inc. Rapid Response 11 Parameters Ultra
K023885	Urine Qualitative Dipstick Ketone	Urinalysis	10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra
K023885	Urine Qualitative Dipstick Bilirubin	Urinalysis	10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra
K023885	Urine Qualitative Dipstick Blood	Urinalysis	10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra
K023885	Urine Qualitative Dipstick Glucose	Urinalysis	10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra
K023885	Urine Qualitative Dipstick Leukocytes	Urinalysis	10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra
K023885	Urine Qualitative Dipstick Nitrite	Urinalysis	10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra
K023885	Urine Qualitative Dipstick Ph	Urinalysis	10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra
K023885	Urine Qualitative Dipstick Protein	Urinalysis	10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra
K023885	Urine Qualitative Dipstick Urobilinogen	Urinalysis	10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra
K023885	Urine Qualitative Dipstick Specific Gravity	Urinalysis	10/27/2006
BTNX Inc. Rapid Response 11 Parameters Ultra
K023885	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	10/27/2006
AgaMatrix GRACEpro Blood Glucose Monitoring System
K052762	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/20/2006
AgaMatrix KeyNote Blood Glucose Monitoring System
K052762	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/20/2006
Clarity H. pylori Rapid Test Device  (Whole Blood)
K024350	Helicobacter Pylori Antibodies	General Immunology	10/20/2006
Tyson Bioresearch Inc. DIACHEX Blood Glucose Monitoring System
K062829	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/20/2006
Genzyme Diagnostics OSOM BVBLUE Test
K050755	Aerobic/Anaerobic Organisms - Vaginal	Bacteriology	10/16/2006
HemoCue Hb 301 System
K061047	Hemoglobin	Hematology	10/10/2006
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K041427	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	10/05/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood)
K955770	Gamma Glutamyl Transferase (GGT)	General Chemistry	10/04/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood)
K950164	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	10/04/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood)
K950164	Alkaline Phosphatase (ALP)	General Chemistry	10/04/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood)
K950164	Amylase	General Chemistry	10/04/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood)
K942782	Albumin	General Chemistry	10/04/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood)
K942782	Protein, Total	General Chemistry	10/04/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood)
K942782	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	10/04/2006
Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood)
K942782	Bilirubin, Total	General Chemistry	10/04/2006
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K050077	Urea (BUN)	General Chemistry	10/04/2006
Biosite Triage Meterpro  (Whole Blood)
K021317	B-Type Natriuretic Peptide (BNP)	General Chemistry	10/04/2006
Card Guard Scientific Survival Ltd. SelfCheck Gluco Diabetes Blood Glucose Test System
K061528	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/04/2006
Little Nell Labs ThyroChek TSH   (Whole Blood)
K990658	Thyroid Stimulating Hormone (TSH)	Endocrinology	10/04/2006
i-Sens Inc. CareSense Blood Glucose Monitoring System
K051651	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/02/2006
EPS Bio Technology Easy Plus Blood Glucose Monitoring System
K061992	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/22/2006
OcculTech Fecal Occult Blood Rapid Test
K060953	Fecal Occult Blood	General Chemistry	09/22/2006
ESA Biosciences LeadCare II Blood Lead Testing System  (Whole Blood)
K052549	Blood Lead	Toxicology / TDM	09/18/2006
Runbio Biotech Co., Ltd. David Pregnancy Test (Midstream)
K053236	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/05/2006
Runbio Biotech Co., Ltd. David Pregnancy Test (Strip)
K053236	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/05/2006
UltraCrit
BK050056	Hematocrit	Hematology	08/31/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup
K050878	Amphetamines	Toxicology / TDM	08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup
K050878	Cannabinoids (THC)	Toxicology / TDM	08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup
K050878	Phencyclidine (PCP)	Toxicology / TDM	08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup
K050878	Cocaine Metabolites	Toxicology / TDM	08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup
K050878	Opiates	Toxicology / TDM	08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup
K050878	Methamphetamine/Amphetamine	Toxicology / TDM	08/21/2006
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup
K050878	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	08/21/2006
ACON Laboratories Inc. Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Ketone	Urinalysis	08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Bilirubin	Urinalysis	08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Blood	Urinalysis	08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Glucose	Urinalysis	08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Leukocytes	Urinalysis	08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Nitrite	Urinalysis	08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Ph	Urinalysis	08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Protein	Urinalysis	08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Urobilinogen	Urinalysis	08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Specific Gravity	Urinalysis	08/14/2006
ACON Laboratories Inc. Urinalysis Reagent Strips
K061559	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	08/14/2006
Teco Rapid Fecal Occult Blood (FOB) Card Test
K061065	Fecal Occult Blood	General Chemistry	08/09/2006
Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana (THC)
K040327	Cannabinoids (THC)	Toxicology / TDM	08/08/2006
Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana and Cocaine (THC, COC)
K040327	Cannabinoids (THC)	Toxicology / TDM	08/08/2006
Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana and Cocaine (THC, COC)
K040327	Cocaine Metabolites	Toxicology / TDM	08/08/2006
WayPoint Biomedical Inc. Health Essist Home Drug Test Marijuana and Cocaine
K050936	Cocaine Metabolites	Toxicology / TDM	08/08/2006
Waypoint Biomedical, Inc. Health Essist Home Drug Test Marijuana and Cocaine
K050936	Cannabinoids (THC)	Toxicology / TDM	08/08/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL
K970250	Urine Qualitative Dipstick Ketone	Urinalysis	08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL
K970250	Urine Qualitative Dipstick Bilirubin	Urinalysis	08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL
K970250	Urine Qualitative Dipstick Blood	Urinalysis	08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL
K970250	Urine Qualitative Dipstick Glucose	Urinalysis	08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL
K970250	Urine Qualitative Dipstick Leukocytes	Urinalysis	08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL
K970250	Urine Qualitative Dipstick Nitrite	Urinalysis	08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL
K970250	Urine Qualitative Dipstick Ph	Urinalysis	08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL
K970250	Urine Qualitative Dipstick Protein	Urinalysis	08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL
K970250	Urine Qualitative Dipstick Urobilinogen	Urinalysis	08/07/2006
Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL
K970250	Urine Qualitative Dipstick Specific Gravity	Urinalysis	08/07/2006
ENTERIX INSURE II FECAL IMMUNOCHEMICAL TEST
K060930	Fecal Occult Blood	General Chemistry	08/03/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips
K023885	Urine Qualitative Dipstick Ketone	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips
K023885	Urine Qualitative Dipstick Bilirubin	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips
K023885	Urine Qualitative Dipstick Blood	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips
K023885	Urine Qualitative Dipstick Glucose	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips
K023885	Urine Qualitative Dipstick Leukocytes	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips
K023885	Urine Qualitative Dipstick Nitrite	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips
K023885	Urine Qualitative Dipstick Ph	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips
K023885	Urine Qualitative Dipstick Protein	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips
K023885	Urine Qualitative Dipstick Urobilinogen	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips
K023885	Urine Qualitative Dipstick Specific Gravity	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips
K023885	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips
K023885	Urine Qualitative Dipstick Ketone	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips
K023885	Urine Qualitative Dipstick Bilirubin	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips
K023885	Urine Qualitative Dipstick Blood	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips
K023885	Urine Qualitative Dipstick Glucose	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips
K023885	Urine Qualitative Dipstick Leukocytes	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips
K023885	Urine Qualitative Dipstick Nitrite	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips
K023885	Urine Qualitative Dipstick Ph	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips
K023885	Urine Qualitative Dipstick Protein	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips
K023885	Urine Qualitative Dipstick Urobilinogen	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips
K023885	Urine Qualitative Dipstick Specific Gravity	Urinalysis	07/27/2006
Analyticon Biotechnologies AG Combi-Screen Urine Test Strips
K023885	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	07/27/2006
Diagnostic Devices Prodigy Blood Glucose Test System
K060467	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/27/2006
Home Diagnostics Element Blood Glucose Monitoring System
K060793	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/27/2006
PerMaxim RediScreen Mononucleosis  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	07/27/2006
IRIS vChem 10 SG Urine Chemistry Stips
K861255	Urine Qualitative Dipstick Bilirubin	Urinalysis	07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Ketone	Urinalysis	07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Blood	Urinalysis	07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Glucose	Urinalysis	07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Leukocytes	Urinalysis	07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Nitrite	Urinalysis	07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Ph	Urinalysis	07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Protein	Urinalysis	07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Urobilinogen	Urinalysis	07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Specific Gravity	Urinalysis	07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	07/13/2006
IRIS vChem 2 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Glucose	Urinalysis	07/13/2006
IRIS vChem 2 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	07/13/2006
IRIS vChem 2 Urine Chemstry Strips
K861255	Urine Qualitative Dipstick Protein	Urinalysis	07/13/2006
IRIS vChem 6 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Ketone	Urinalysis	07/13/2006
IRIS vChem 6 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Blood	Urinalysis	07/13/2006
IRIS vChem 6 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Glucose	Urinalysis	07/13/2006
IRIS vChem 6 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Leukocytes	Urinalysis	07/13/2006
IRIS vChem 6 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Ph	Urinalysis	07/13/2006
IRIS vChem 6 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Protein	Urinalysis	07/13/2006
IRIS vChem 6 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	07/13/2006
IRIS vChem 8 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Ketone	Urinalysis	07/13/2006
IRIS vChem 8 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Bilirubin	Urinalysis	07/13/2006
IRIS vChem 8 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Blood	Urinalysis	07/13/2006
IRIS vChem 8 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Glucose	Urinalysis	07/13/2006
IRIS vChem 8 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Nitrite	Urinalysis	07/13/2006
IRIS vChem 8 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Ph	Urinalysis	07/13/2006
IRIS vChem 8 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Protein	Urinalysis	07/13/2006
IRIS vChem 8 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Urobilinogen	Urinalysis	07/13/2006
IRIS vChem 8 Urine Chemistry Strips
K861255	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	07/13/2006
Diagnostic Devices, Inc. Prodigy Blood Glucose Monitoring System
K053593	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/07/2006
i-Sense Inc. CareSens Blood Glucose Monitoring System
K051651	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/07/2006
Beckman Coulter ICON HP test  ((for whole blood))
K980798	Helicobacter Pylori Antibodies	General Immunology	06/30/2006
Beckman Coulter ICON SC Strep A test
K040708	Streptococcus, Group A	Bacteriology	06/30/2006
Gryphus Diagnostics BVBlue
K050755	Aerobic/Anaerobic Organisms - Vaginal	Bacteriology	06/30/2006
PFIZER CONSUMER HEALTHCARE e.p.t. Certainty 1-Step Pregnancy Test
K061769	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/30/2006
Taidoc Technology easy check TD-4209 Blood Glucose Monitoring System
K042005	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/30/2006
Tyson Bioresearch, Inc. EZ-Smart-168 Blood Glucose Monitoring System
K052818	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/30/2006
Mizuho USA Multi-Use Electronic Pregnancy Test
K060825	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/20/2006
Diagnostic Test Group, Clarity Blood Glucose Monitoring System
K051854	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/15/2006
HealthPia America Corporation, GlucoPack Blood Glucose Monitoring System
K052469	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/15/2006
Immunostics, Inc., hema-screen SPECIFIC Immunochemical Fecal Occult Blood Test
K060463	Fecal Occult Blood	General Chemistry	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine
K040629	Amphetamines	Toxicology / TDM	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine
K040629	Cannabinoids (THC)	Toxicology / TDM	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine
K040629	Phencyclidine (PCP)	Toxicology / TDM	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine
K040629	Cocaine Metabolites	Toxicology / TDM	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine
K040629	Opiates	Toxicology / TDM	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine
K040629	Methamphetamines	Toxicology / TDM	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine
K041221	Amphetamines	Toxicology / TDM	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine
K041221	Cannabinoids (THC)	Toxicology / TDM	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine
K041221	Phencyclidine (PCP)	Toxicology / TDM	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine
K041221	Cocaine Metabolites	Toxicology / TDM	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine
K041221	Opiates	Toxicology / TDM	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine
K041221	Methamphetamines	Toxicology / TDM	06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine
K041221	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	06/15/2006
Taidoc Clever Chek TD-3250 Blood Glucose Plus Blood Pressure Monitoring System
K061073	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/06/2006
Inverness Medical, Inc. Clearblue Easy Digital Pregnancy Test
K060128	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/01/2006
Kareway Product Pure-Aid Pregnancy Test
K053452	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/31/2006
Meridian Bioscience Immunocard STAT! HpSA  (Stool)
K032222	Helicobacter Pylori	Bacteriology	05/31/2006
BTNX Inc. Rapid Response One Step hCG Pregnancy Urine Test Cassette
K050305	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/22/2006
BTNX Inc. Rapid Response One Step hCG Pregnancy Urine Test Strip
K050305	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/22/2006
BTNX Inc. Rapid Response One Step hCG Pregnancy Urine/Serum Combo Cassette Test
K050305	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Bilirubin	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Blood	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Ph	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Protein	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Urobilinogen	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 10 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 2 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 2 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Protein	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 4 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 4 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 4 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	05/22/2006
Jant Pharmacal Accutest URS 4 Urine Reagent Strips
K993850	Urine Qualitative Dipstick Protein	Urinalysis	05/22/2006
LifeScan OneTouch UltraMini Blood Glucose Monitoring System
K061118	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/22/2006
Progressive Health Supply and Source Smartest Protege Blood Glucose Monitoring System
K032029	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/22/2006
CEN-MED Elite Plus hCG One Step Pregnancy Test Device (Urine/Serum)
K981165	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/15/2006
Abbott Diabetes Care Inc. Optium Blood Glucose Monitoring System
K033845	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device
K041685	Amphetamines	Toxicology / TDM	05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device
K041685	Cannabinoids (THC)	Toxicology / TDM	05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device
K041685	Phencyclidine (PCP)	Toxicology / TDM	05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device
K041685	Cocaine Metabolites	Toxicology / TDM	05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device
K041685	Propoxyphene	Toxicology / TDM	05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device
K041685	Benzodiazepines	Toxicology / TDM	05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device
K041685	Barbiturates	Toxicology / TDM	05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device
K041685	Morphine	Toxicology / TDM	05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device
K041685	Tricyclic Antidepressants	Toxicology / TDM	05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device
K041685	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/01/2006
Acon Laboratories Multi-Clin Drug Screen Test Device
K041685	Oxycodone	Toxicology / TDM	05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device
K041743	Amphetamines	Toxicology / TDM	05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device
K041743	Cannabinoids (THC)	Toxicology / TDM	05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device
K041743	Phencyclidine (PCP)	Toxicology / TDM	05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device
K041743	Cocaine Metabolites	Toxicology / TDM	05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device
K041743	Propoxyphene	Toxicology / TDM	05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device
K041743	Benzodiazepines	Toxicology / TDM	05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device
K041743	Barbiturates	Toxicology / TDM	05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device
K041743	Morphine	Toxicology / TDM	05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device
K041743	Tricyclic Antidepressants	Toxicology / TDM	05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device
K041743	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/01/2006
Acon Laboratories Tri-Fect Drug Screen Test Device
K041743	Oxycodone	Toxicology / TDM	05/01/2006
First Check Diagnostics LLC, First Check Home Drug Test Marijuana
K050936	Cannabinoids (THC)	Toxicology / TDM	05/01/2006
Solartek Products, Inc. Kroger Blood Glucose Monitoring System
K033845	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/01/2006
Solartek Products, Inc. ReliOn Ultima Blood Glucose Monitoring System
K033845	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/01/2006
Solartek Products, Inc. RiteAid Blood Glucose Monitoring System
K033845	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/01/2006
BinaxNOW Influenza A & B Test  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens)
K053126	Influenza A/B	Virology	04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)
K993850	Urine Qualitative Dipstick Bilirubin	Urinalysis	04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)
K993850	Urine Qualitative Dipstick Blood	Urinalysis	04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)
K993850	Urine Qualitative Dipstick Ph	Urinalysis	04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)
K993850	Urine Qualitative Dipstick Protein	Urinalysis	04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)
K993850	Urine Qualitative Dipstick Urobilinogen	Urinalysis	04/19/2006
MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	04/19/2006
Noble Medical Inc. Split-Specimen Cup
K050878	Amphetamines	Toxicology / TDM	04/19/2006
Noble Medical Inc. Split-Specimen Cup
K050878	Cannabinoids (THC)	Toxicology / TDM	04/19/2006
Noble Medical Inc. Split-Specimen Cup
K050878	Phencyclidine (PCP)	Toxicology / TDM	04/19/2006
Noble Medical Inc. Split-Specimen Cup
K050878	Cocaine Metabolites	Toxicology / TDM	04/19/2006
Noble Medical Inc. Split-Specimen Cup
K050878	Opiates	Toxicology / TDM	04/19/2006
Noble Medical Inc. Split-Specimen Cup
K050878	Methamphetamines	Toxicology / TDM	04/19/2006
Noble Medical Inc. Split-Specimen Cup
K050878	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	04/19/2006
US Diagnostics, Inc. G4 Blood Glucose Monitoring System
K051651	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/19/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis
K052525	Urine Qualitative Dipstick Ketone	Urinalysis	04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis
K052525	Urine Qualitative Dipstick Bilirubin	Urinalysis	04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis
K052525	Urine Qualitative Dipstick Blood	Urinalysis	04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis
K052525	Urine Qualitative Dipstick Glucose	Urinalysis	04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis
K052525	Urine Qualitative Dipstick Nitrite	Urinalysis	04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis
K052525	Urine Qualitative Dipstick Ph	Urinalysis	04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis
K052525	Urine Qualitative Dipstick Protein	Urinalysis	04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis
K052525	Urine Qualitative Dipstick Specific Gravity	Urinalysis	04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis
K052525	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis
K052525	Urine Qualitative Dipstick Leukocytes	Urinalysis	04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis
K052525	Urine Qualitative Dipstick Urobilinogen	Urinalysis	04/11/2006
Polymer Technology Systems CardioChek Analyzer {PTS PANELS HDL Cholesterol Test Strips}
K060617	HDL Cholesterol	General Chemistry	04/10/2006
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS HDL Cholesterol Test Strips}
K060617	HDL Cholesterol	General Chemistry	04/10/2006
Hypoguard Assure Pro Blood Glucose Monitoring System
K053079	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2006
Rapid Pathogen Screening RPS Adeno Detector
K052092	Adenovirus	Virology	03/30/2006
immoCARE Fecal Occult Blood Test
K052598	Fecal Occult Blood	General Chemistry	03/22/2006
Abbott Freestyle Feedom Blood Glucose Monitoring System
K051839	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/13/2006
Johnson & Johnson, Lifescan, Inc. One Touch Basic Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip}
K052207	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/13/2006
Johnson & Johnson, Lifescan, Inc. One Touch II Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip}
K052207	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/13/2006
Johnson & Johnson, Lifescan, Inc. One Touch Profile Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip}
K052207	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL
K991927	Urine Qualitative Dipstick Ketone	Urinalysis	03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL
K991927	Urine Qualitative Dipstick Bilirubin	Urinalysis	03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL
K991927	Urine Qualitative Dipstick Blood	Urinalysis	03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL
K991927	Urine Qualitative Dipstick Glucose	Urinalysis	03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL
K991927	Urine Qualitative Dipstick Leukocytes	Urinalysis	03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL
K991927	Urine Qualitative Dipstick Nitrite	Urinalysis	03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL
K991927	Urine Qualitative Dipstick Ph	Urinalysis	03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL
K991927	Urine Qualitative Dipstick Protein	Urinalysis	03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL
K991927	Urine Qualitative Dipstick Urobilinogen	Urinalysis	03/13/2006
MACHEREY-NAGEL Medi-Test Combi 10 SGL
K991927	Urine Qualitative Dipstick Specific Gravity	Urinalysis	03/13/2006
Bioptik Technology, Inc. EasyMate Blood Glucose Monitoring System
K053312	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/09/2006
Ani Biotech Oy MySet Pregnancy Test
K053138	hCG, Urine	Endocrinology	03/03/2006
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device
K050050	Amphetamines	Toxicology / TDM	03/03/2006
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device
K050050	Cannabinoids (THC)	Toxicology / TDM	03/03/2006
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device
K050050	Phencyclidine (PCP)	Toxicology / TDM	03/03/2006
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device
K050050	Cocaine Metabolites	Toxicology / TDM	03/03/2006
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device
K050050	Opiates	Toxicology / TDM	03/03/2006
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device
K050050	Methamphetamines	Toxicology / TDM	03/03/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup
K050878	Amphetamines	Toxicology / TDM	02/27/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup
K050878	Cannabinoids (THC)	Toxicology / TDM	02/27/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup
K050878	Phencyclidine (PCP)	Toxicology / TDM	02/27/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup
K050878	Cocaine Metabolites	Toxicology / TDM	02/27/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup
K050878	Opiates	Toxicology / TDM	02/27/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup
K050878	Methamphetamines	Toxicology / TDM	02/27/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup
K050878	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	02/27/2006
Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Cassette
K060019	hCG, Urine	Endocrinology	02/22/2006
Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Midstream
K060019	hCG, Urine	Endocrinology	02/22/2006
Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Strip
K060019	hCG, Urine	Endocrinology	02/22/2006
Artron One-Step Pregnancy Test
K060019	hCG, Urine	Endocrinology	02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Blood	Urinalysis	02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Ph	Urinalysis	02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Protein	Urinalysis	02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/22/2006
Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/22/2006
First Check Diagnostics First Check 12 Drug Test
K052115	Amphetamines	Toxicology / TDM	02/22/2006
First Check Diagnostics First Check 12 Drug Test
K052115	Cannabinoids (THC)	Toxicology / TDM	02/22/2006
First Check Diagnostics First Check 12 Drug Test
K052115	Phencyclidine (PCP)	Toxicology / TDM	02/22/2006
First Check Diagnostics First Check 12 Drug Test
K052115	Cocaine Metabolites	Toxicology / TDM	02/22/2006
First Check Diagnostics First Check 12 Drug Test
K052115	Opiates	Toxicology / TDM	02/22/2006
First Check Diagnostics First Check 12 Drug Test
K052115	Methadone	Toxicology / TDM	02/22/2006
First Check Diagnostics First Check 12 Drug Test
K052115	Methamphetamines	Toxicology / TDM	02/22/2006
First Check Diagnostics First Check 12 Drug Test
K052115	Benzodiazepines	Toxicology / TDM	02/22/2006
First Check Diagnostics First Check 12 Drug Test
K052115	Barbiturates	Toxicology / TDM	02/22/2006
First Check Diagnostics First Check 12 Drug Test
K052115	Tricyclic Antidepressants	Toxicology / TDM	02/22/2006
First Check Diagnostics First Check 12 Drug Test
K052115	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	02/22/2006
First Check Diagnostics First Check 12 Drug Test
K052115	Oxycodone	Toxicology / TDM	02/22/2006
Genzyme Sure-Vue Signature MONO Test  (Whole Blood)
K972231	Infectious Mononucleosis Antibodies (Mono)	General Immunology	02/22/2006
Germaine Laboratories AimStick 10-SG
K051727	Urine Qualitative Dipstick Chemistries	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-2
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-2
K051727	Urine Qualitative Dipstick Protein	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-2GK
K051727	Urine Qualitative Dipstick Ketone	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-2GK
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-2GpH
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-2GpH
K051727	Urine Qualitative Dipstick Ph	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-2LN
K051727	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-2LN
K051727	Urine Qualitative Dipstick Nitrite	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-3
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-3
K051727	Urine Qualitative Dipstick Ph	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-3
K051727	Urine Qualitative Dipstick Protein	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-4
K051727	Urine Qualitative Dipstick Blood	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-4
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-4
K051727	Urine Qualitative Dipstick Ph	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-4
K051727	Urine Qualitative Dipstick Protein	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-4OB
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-4OB
K051727	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-4OB
K051727	Urine Qualitative Dipstick Nitrite	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-4OB
K051727	Urine Qualitative Dipstick Protein	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-5
K051727	Urine Qualitative Dipstick Ketone	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-5
K051727	Urine Qualitative Dipstick Blood	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-5
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-5
K051727	Urine Qualitative Dipstick Ph	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-5
K051727	Urine Qualitative Dipstick Protein	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-6
K051727	Urine Qualitative Dipstick Ketone	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-6
K051727	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-6
K051727	Urine Qualitative Dipstick Blood	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-6
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-6
K051727	Urine Qualitative Dipstick Ph	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-6
K051727	Urine Qualitative Dipstick Protein	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-7
K051727	Urine Qualitative Dipstick Ketone	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-7
K051727	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-7
K051727	Urine Qualitative Dipstick Blood	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-7
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-7
K051727	Urine Qualitative Dipstick Ph	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-7
K051727	Urine Qualitative Dipstick Protein	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-7
K051727	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-8
K051727	Urine Qualitative Dipstick Ketone	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-8
K051727	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-8
K051727	Urine Qualitative Dipstick Blood	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-8
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-8
K051727	Urine Qualitative Dipstick Nitrite	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-8
K051727	Urine Qualitative Dipstick Ph	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-8
K051727	Urine Qualitative Dipstick Protein	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-8
K051727	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-9
K051727	Urine Qualitative Dipstick Ketone	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-9
K051727	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-9
K051727	Urine Qualitative Dipstick Blood	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-9
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-9
K051727	Urine Qualitative Dipstick Nitrite	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-9
K051727	Urine Qualitative Dipstick Ph	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-9
K051727	Urine Qualitative Dipstick Protein	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-9
K051727	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-9
K051727	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-B
K051727	Urine Qualitative Dipstick Blood	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-BR
K051727	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-G
K051727	Urine Qualitative Dipstick Glucose	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-K
K051727	Urine Qualitative Dipstick Ketone	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-L
K051727	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-N
K051727	Urine Qualitative Dipstick Nitrite	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-P
K051727	Urine Qualitative Dipstick Protein	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-pH
K051727	Urine Qualitative Dipstick Ph	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-SG
K051727	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/22/2006
Germaine Laboratories AimStick US-U
K051727	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/22/2006
ImmuLab, Inc. One Step Pregnancy Test Strip (Urine)
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/22/2006
Instant Technologies Inc. One Step LH Ovulation Test Cassette
X050002	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	02/22/2006
Instant Technologies Inc. One Step LH Ovulation Test Strip
X050002	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	02/22/2006
Lifescan One Touch Ultra 2 Blood Glucose Monitoring System
K053529	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/22/2006
RAC Medical Clarity MONO Mononucleosis Rapid Test Device  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	02/22/2006
Saless Enterprises Inc. One Step LH Ovulation Test Cassette
X050002	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	02/22/2006
Axis-Shield Afinion AS100 Analyzer
K050574	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	02/17/2006
Albertsons Equaline Sidekick Blood Glucose Testing System
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2006
Chain Drug Consortium Premier Value Sidekick Blood Glucose Testing System
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD
K993850	Urine Qualitative Dipstick Blood	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD
K993850	Urine Qualitative Dipstick Ph	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD
K993850	Urine Qualitative Dipstick Protein	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES
K993850	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES
K993850	Urine Qualitative Dipstick Blood	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES
K993850	Urine Qualitative Dipstick Ph	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES
K993850	Urine Qualitative Dipstick Protein	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES
K993850	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/09/2006
CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin
K993850	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin
K993850	Urine Qualitative Dipstick Blood	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin
K993850	Urine Qualitative Dipstick Ph	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin
K993850	Urine Qualitative Dipstick Protein	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite
K993850	Urine Qualitative Dipstick Blood	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite
K993850	Urine Qualitative Dipstick Ph	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite
K993850	Urine Qualitative Dipstick Protein	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity
K993850	Urine Qualitative Dipstick Blood	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity
K993850	Urine Qualitative Dipstick Ph	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity
K993850	Urine Qualitative Dipstick Protein	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen
K993850	Urine Qualitative Dipstick Blood	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen
K993850	Urine Qualitative Dipstick Ph	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen
K993850	Urine Qualitative Dipstick Protein	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen
K993850	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/09/2006
McKesson SunMark Sidekick Blood Glucose Testing System
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2006
Safeway Sidekick Blood Glucose Testing System
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2006
AgaMatrix Liberty Blood Glucose Monitoring System
K052762	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/24/2006
AgaMatrix Liberty Blood Glucose Monitoring System {Professional Use}
K052762	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/24/2006
DE Healthcare Products Ultrascreen 10+SG
K991927	Urine Qualitative Dipstick Ketone	Urinalysis	01/24/2006
DE Healthcare Products Ultrascreen 10+SG
K991927	Urine Qualitative Dipstick Bilirubin	Urinalysis	01/24/2006
DE Healthcare Products Ultrascreen 10+SG
K991927	Urine Qualitative Dipstick Blood	Urinalysis	01/24/2006
DE Healthcare Products Ultrascreen 10+SG
K991927	Urine Qualitative Dipstick Glucose	Urinalysis	01/24/2006
DE Healthcare Products Ultrascreen 10+SG
K991927	Urine Qualitative Dipstick Leukocytes	Urinalysis	01/24/2006
DE Healthcare Products Ultrascreen 10+SG
K991927	Urine Qualitative Dipstick Nitrite	Urinalysis	01/24/2006
DE Healthcare Products Ultrascreen 10+SG
K991927	Urine Qualitative Dipstick Ph	Urinalysis	01/24/2006
DE Healthcare Products Ultrascreen 10+SG
K991927	Urine Qualitative Dipstick Protein	Urinalysis	01/24/2006
DE Healthcare Products Ultrascreen 10+SG
K991927	Urine Qualitative Dipstick Urobilinogen	Urinalysis	01/24/2006
DE Healthcare Products Ultrascreen 10+SG
K991927	Urine Qualitative Dipstick Specific Gravity	Urinalysis	01/24/2006
DE Healthcare Products Ultrascreen 10+SG
K991927	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	01/24/2006
First Check Diagnostics First Check Multi Drug Cup
K051966	Amphetamines	Toxicology / TDM	01/17/2006
First Check Diagnostics First Check Multi Drug Cup
K051966	Cannabinoids (THC)	Toxicology / TDM	01/17/2006
First Check Diagnostics First Check Multi Drug Cup
K051966	Phencyclidine (PCP)	Toxicology / TDM	01/17/2006
First Check Diagnostics First Check Multi Drug Cup
K051966	Cocaine Metabolites	Toxicology / TDM	01/17/2006
First Check Diagnostics First Check Multi Drug Cup
K051966	Opiates	Toxicology / TDM	01/17/2006
First Check Diagnostics First Check Multi Drug Cup
K051966	Methamphetamines	Toxicology / TDM	01/17/2006
First Check Diagnostics First Check Multi Drug Cup
K051966	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	01/17/2006
Biotechnostix, Inc. Rapid Response FSH One Step Menopause Test Device  (Professional Use)
K041165	Follicle Stimulating Hormone (FSH)	Endocrinology	01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115	Amphetamines	Toxicology / TDM	01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115	Cannabinoids (THC)	Toxicology / TDM	01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115	Phencyclidine (PCP)	Toxicology / TDM	01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115	Cocaine Metabolites	Toxicology / TDM	01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115	Opiates	Toxicology / TDM	01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115	Methadone	Toxicology / TDM	01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115	Methamphetamines	Toxicology / TDM	01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115	Benzodiazepines	Toxicology / TDM	01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115	Barbiturates	Toxicology / TDM	01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115	Tricyclic Antidepressants	Toxicology / TDM	01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115	Oxycodone	Toxicology / TDM	01/10/2006
RAC Medical Clarity FSH One Step Menopause Test Device  (Professional Use)
K041165	Follicle Stimulating Hormone (FSH)	Endocrinology	01/10/2006
IND Diagnostic Inc. One Step HCG Pregnancy Test 2000 mIU/mL
K052694	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/19/2005
Rapid Response Mononucleosis Rapid Test Device (whole blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	12/15/2005
Aventir Biotech, LLC Glucose Pilot Monitoring System
K052208	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/12/2005
Sein Electronics Blood Glucose and Blood Pressure Measurement System, Model BGP-100
K052108	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/08/2005
Runbio Biotech Co., Ltd. David Ovulation Test
K053239	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	12/07/2005
Runbio Biotech Co., Ltd. David Ovulation Test
K053238	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	12/06/2005
IND Diagnostic INC. One Step FSH Menopausal Test (Cassette)
K052662	Follicle Stimulating Hormone (FSH)	Endocrinology	12/02/2005
IND Diagnostic INC. One Step FSH Menopausal Test (midstream)
K052662	Follicle Stimulating Hormone (FSH)	Endocrinology	12/02/2005
IND Diagnostic INC. One Step FSH Menopausal Test (Strip)
K052662	Follicle Stimulating Hormone (FSH)	Endocrinology	12/02/2005
IND Diagnostic, Inc. One Step Cassette Style FSH Menopausal Test  (Professional Use)
K052662	Follicle Stimulating Hormone (FSH)	Endocrinology	12/02/2005
IND Diagnostic, Inc. One Step Strip Style FSH Menopausal Test  (Professional Use)
K052662	Follicle Stimulating Hormone (FSH)	Endocrinology	12/02/2005
Target Corporation EasyPRO Blood Glucose Mornitoring System
K031388	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/02/2005
BioJENC Uro-nDip UTI Urinalysis Reagent Strip
X050011	Urine Qualitative Dipstick Nitrite	Urinalysis	11/29/2005
BioJENC Uro-nDip UTI Urinalysis Reagent Strip
X050011	Urine Qualitative Dipstick Ph	Urinalysis	11/29/2005
Henry Schein Urispec 11-Way Reagent Strip
K991927	Urine Qualitative Dipstick Ketone	Urinalysis	11/29/2005
Henry Schein Urispec 11-Way Reagent Strip
K991927	Urine Qualitative Dipstick Bilirubin	Urinalysis	11/29/2005
Henry Schein Urispec 11-Way Reagent Strip
K991927	Urine Qualitative Dipstick Blood	Urinalysis	11/29/2005
Henry Schein Urispec 11-Way Reagent Strip
K991927	Urine Qualitative Dipstick Glucose	Urinalysis	11/29/2005
Henry Schein Urispec 11-Way Reagent Strip
K991927	Urine Qualitative Dipstick Leukocytes	Urinalysis	11/29/2005
Henry Schein Urispec 11-Way Reagent Strip
K991927	Urine Qualitative Dipstick Nitrite	Urinalysis	11/29/2005
Henry Schein Urispec 11-Way Reagent Strip
K991927	Urine Qualitative Dipstick Ph	Urinalysis	11/29/2005
Henry Schein Urispec 11-Way Reagent Strip
K991927	Urine Qualitative Dipstick Protein	Urinalysis	11/29/2005
Henry Schein Urispec 11-Way Reagent Strip
K991927	Urine Qualitative Dipstick Urobilinogen	Urinalysis	11/29/2005
Henry Schein Urispec 11-Way Reagent Strip
K991927	Urine Qualitative Dipstick Specific Gravity	Urinalysis	11/29/2005
Henry Schein Urispec 11-Way Reagent Strip
K991927	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-1 Parameter Glucose
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-1 Parameter Ketone
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Ketone
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Ketone
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Protein
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Protein
K993850	Urine Qualitative Dipstick Protein	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein
K993850	Urine Qualitative Dipstick Protein	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes
K993850	Urine Qualitative Dipstick Protein	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood
K993850	Urine Qualitative Dipstick Blood	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood
K993850	Urine Qualitative Dipstick Ph	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood
K993850	Urine Qualitative Dipstick Protein	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone
K993850	Urine Qualitative Dipstick Blood	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone
K993850	Urine Qualitative Dipstick Ph	Urinalysis	11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone
K993850	Urine Qualitative Dipstick Protein	Urinalysis	11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966	Amphetamines	Toxicology / TDM	11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966	Cannabinoids (THC)	Toxicology / TDM	11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966	Phencyclidine (PCP)	Toxicology / TDM	11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966	Cocaine Metabolites	Toxicology / TDM	11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966	Opiates	Toxicology / TDM	11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966	Methamphetamines	Toxicology / TDM	11/29/2005
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	11/29/2005
SA Scientific SAS Influenza A Test
K041441	Influenza A	Virology	11/23/2005
SA Scientific SAS Influenza B Test
K041439	Influenza B	Virology	11/23/2005
QuickVue iFOB Test (Immunochemical Fecal Occult Blood)  (Cassette)
K021423	Fecal Occult Blood	General Chemistry	11/09/2005
Target Corporation EasyPRO Blood Glucose Mornitoring System
K020232	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/09/2005
CAREONE Sidekick Blood Glucose Testing System
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/20/2005
Fisher Scientific Sure-Vue RSV Test
K022845	Respiratory Syncytial Virus	Virology	10/20/2005
Home Diagnostics Inc. Diabetes Centers of America TrueTrack Smart System Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/20/2005
Meridian Bioscience ImmunoCard STAT! RSV PLUS
K041445	Respiratory Syncytial Virus	Virology	10/20/2005
Remel Xpect Rsv
K022845	Respiratory Syncytial Virus	Virology	10/20/2005
SA Scientific SAS RSV Test
K022845	Respiratory Syncytial Virus	Virology	10/20/2005
SA Scientific SAS RSVAlert
K022845	Respiratory Syncytial Virus	Virology	10/20/2005
Care Fecal Occult Blood Test
K051806	Fecal Occult Blood	General Chemistry	10/07/2005
Hypoguard Assure Pro Blood Glucose Monitoring System
K051514	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/07/2005
Instant Technologies iScreen Mononucleosis Rapid Test Device  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	10/07/2005
Instant Technologies iScreen Mononucleosis Rapid Test Strip  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	10/07/2005
Taidoc Prodigy Blood Glucose Monitoring System
K051854	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/07/2005
Hemocue Glucose 201 DM Analyzer
K041230	Glucose	General Chemistry	09/28/2005
Instant Technologies iScreen H. pylori Rapid Test Device
K024350	Helicobacter Pylori Antibodies	General Immunology	09/27/2005
Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips}
K023558	HDL Cholesterol	General Chemistry	09/27/2005
Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips}
K023558	Cholesterol	General Chemistry	09/27/2005
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips}
K023558	HDL Cholesterol	General Chemistry	09/27/2005
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips}
K023558	Cholesterol	General Chemistry	09/27/2005
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use)
K050878	Amphetamines	Toxicology / TDM	09/13/2005
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use)
K050878	Cannabinoids (THC)	Toxicology / TDM	09/13/2005
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use)
K050878	Phencyclidine (PCP)	Toxicology / TDM	09/13/2005
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use)
K050878	Cocaine Metabolites	Toxicology / TDM	09/13/2005
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use)
K050878	Opiates	Toxicology / TDM	09/13/2005
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use)
K050878	Methamphetamines	Toxicology / TDM	09/13/2005
ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use)
K050878	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	09/13/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters
K993850	Urine Qualitative Dipstick Bilirubin	Urinalysis	09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters
K993850	Urine Qualitative Dipstick Blood	Urinalysis	09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters
K993850	Urine Qualitative Dipstick Ph	Urinalysis	09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters
K993850	Urine Qualitative Dipstick Protein	Urinalysis	09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters
K993850	Urine Qualitative Dipstick Urobilinogen	Urinalysis	09/12/2005
Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	09/12/2005
CVS Sidekick Blood Glucose Test System  (Over-The-Counter)
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/09/2005
Good Neighbor Pharmacy Sidekick Blood Glucose Test System  (Over-The-Counter)
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/09/2005
International Newtech Develop. Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	09/09/2005
International Newtech Develop. Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Bilirubin	Urinalysis	09/09/2005
International Newtech Develop. Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Blood	Urinalysis	09/09/2005
International Newtech Develop. Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	09/09/2005
International Newtech Develop. Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	09/09/2005
International Newtech Develop. Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	09/09/2005
International Newtech Develop. Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Ph	Urinalysis	09/09/2005
International Newtech Develop. Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Protein	Urinalysis	09/09/2005
International Newtech Develop. Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Urobilinogen	Urinalysis	09/09/2005
International Newtech Develop. Urinalysis Reagent Strips
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	09/09/2005
Leader Sidekick Blood Glucose Test System  (Over-The-Counter)
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/09/2005
Walgreens Sidekick Blood Glucose Test System  (Over-The-Counter)
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/09/2005
Roche Diagnostics Accu-Chek Go Blood Glucose Monitoring System
K051592	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/08/2005
Bayer Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Bilirubin	Urinalysis	09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Blood	Urinalysis	09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Glucose	Urinalysis	09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Leukocytes	Urinalysis	09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Nitrite	Urinalysis	09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Ph	Urinalysis	09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Protein	Urinalysis	09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Urobilinogen	Urinalysis	09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Specific Gravity	Urinalysis	09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Creatinine	Urinalysis	09/07/2005
Bayer Clinitek Status Urine Chemistry Analyzer
K031947	Urine Qualitative Dipstick Ketone	Urinalysis	09/07/2005
accutest Multi-Drug, Multi-Line Screen Device
K050050	Amphetamines	Toxicology / TDM	09/01/2005
accutest Multi-Drug, Multi-Line Screen Device
K050050	Cannabinoids (THC)	Toxicology / TDM	09/01/2005
accutest Multi-Drug, Multi-Line Screen Device
K050050	Phencyclidine (PCP)	Toxicology / TDM	09/01/2005
accutest Multi-Drug, Multi-Line Screen Device
K050050	Cocaine Metabolites	Toxicology / TDM	09/01/2005
accutest Multi-Drug, Multi-Line Screen Device
K050050	Opiates	Toxicology / TDM	09/01/2005
accutest Multi-Drug, Multi-Line Screen Device
K050050	Methamphetamines	Toxicology / TDM	09/01/2005
ACON Mononucleosis Rapid Test Device  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	09/01/2005
ACON Mononucleosis Rapid Test Strip  (Whole Blood)
K042272	Infectious Mononucleosis Antibodies (Mono)	General Immunology	09/01/2005
RediScreen Multi-Drug, Multi-Line Screen Test Device
K050050	Amphetamines	Toxicology / TDM	09/01/2005
RediScreen Multi-Drug, Multi-Line Screen Test Device
K050050	Cannabinoids (THC)	Toxicology / TDM	09/01/2005
RediScreen Multi-Drug, Multi-Line Screen Test Device
K050050	Phencyclidine (PCP)	Toxicology / TDM	09/01/2005
RediScreen Multi-Drug, Multi-Line Screen Test Device
K050050	Cocaine Metabolites	Toxicology / TDM	09/01/2005
RediScreen Multi-Drug, Multi-Line Screen Test Device
K050050	Opiates	Toxicology / TDM	09/01/2005
RediScreen Multi-Drug, Multi-Line Screen Test Device
K050050	Methamphetamines	Toxicology / TDM	09/01/2005
Biosite Triage Meter  (Whole Blood)
K021317	B-Type Natriuretic Peptide (BNP)	General Chemistry	08/26/2005
Biosite Triage Meter Plus  (Whole Blood)
K021317	B-Type Natriuretic Peptide (BNP)	General Chemistry	08/26/2005
Acon Laboratories, Inc. FSH One Step Menopause Test Device  (Professional Use)
K041165	Follicle Stimulating Hormone (FSH)	Endocrinology	08/24/2005
Acon Laboratories, Inc. FSH One Step Menopause Test Strip  (Professional Use)
K041165	Follicle Stimulating Hormone (FSH)	Endocrinology	08/24/2005
Roche Diagnostics AccuChek Instant Plus Dual Testing System
K051376	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/24/2005
Roche Diagnostics AccuChek Instant Plus Dual Testing System
K051376	Cholesterol	General Chemistry	08/24/2005
Brooks Pharmacy Sidekick Blood Glucose Test System
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/22/2005
Eckerd Pharmacy Sidekick Blood Glucose Test System
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/22/2005
McKesson SunMark Performance Plus Sidekick Blood Glucose Test System
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/22/2005
Medicine Shoppe Sidekick Blood Glucose Test System
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/22/2005
Meijer Sidekick Blood Glucose Test System
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/22/2005
WH Accu Test One-Step Urine/Serum Pregnancy Test
K051841	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/22/2005
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K942782	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	08/16/2005
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K942782	Glucose	General Chemistry	08/16/2005
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K950164	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	08/16/2005
Abbott Freestyle Connect Blood Glucose Monitoring System
K051802	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/11/2005
BIOMEDIX INC. Q STEPS Biometer G/C Dual Monitoring System
K050182	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/11/2005
BIOMEDIX INC. Q STEPS Biometer G/C Dual Monitoring System
K050182	Cholesterol	General Chemistry	08/11/2005
Taidoc Clever Chek TD-3215 Blood Glucose and Blood Pressure Measurement System
K051936	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/11/2005
Taidoc Dr. T TD-3216 Blood Glucose and Blood Pressure Measurement System
K051936	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/11/2005
Infopia Co., Ltd. GLucoLab Blood Glucose Monitoring System {Home Use}
K051285	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/09/2005
Infopia Co., Ltd. GLucoLab Blood Glucose Monitoring System {Professional Use}
K051285	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/09/2005
Taidoc Clever Chek Blood Glucose Monitoring System TD-4225
K051854	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/09/2005
McKesson Corporation Medi-Lab Performance hCG Urine - Cassette
K953988	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/01/2005
Mizuho USA Proof Positive
K000844	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/01/2005
Wampole Laboratories Clearview hCG II
K953988	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/01/2005
Branan Medical Corporation ToxCup Drug Screen Cup
K032057	Amphetamines	Toxicology / TDM	07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup
K032057	Cannabinoids (THC)	Toxicology / TDM	07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup
K032057	Phencyclidine (PCP)	Toxicology / TDM	07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup
K032057	Cocaine Metabolites	Toxicology / TDM	07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup
K032057	Opiates	Toxicology / TDM	07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup
K032057	Methadone	Toxicology / TDM	07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup
K032057	Methamphetamines	Toxicology / TDM	07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup
K032057	Benzodiazepines	Toxicology / TDM	07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup
K032057	Barbiturates	Toxicology / TDM	07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup
K032057	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup
K032057	Oxycodone	Toxicology / TDM	07/19/2005
3test Blood Glucose Monitoirng System
K050224	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/14/2005
Home Diagnostics Sidekick Blood Glucose Testing System
K051147	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/14/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K042443	Triglyceride	General Chemistry	07/12/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K042443	HDL Cholesterol	General Chemistry	07/12/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K042443	Cholesterol	General Chemistry	07/12/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K040332	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	07/12/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K040332	Glucose	General Chemistry	07/12/2005
Perrigo Company +/- Pregnancy Test
K050546	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/12/2005
iCassette Multi-Drug, Multi-Line Screen Test Device
K050050	Amphetamines	Toxicology / TDM	07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device
K050050	Cannabinoids (THC)	Toxicology / TDM	07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device
K050050	Phencyclidine (PCP)	Toxicology / TDM	07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device
K050050	Cocaine Metabolites	Toxicology / TDM	07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device
K050050	Opiates	Toxicology / TDM	07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device
K050050	Methamphetamines	Toxicology / TDM	07/08/2005
Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device
K050050	Amphetamines	Toxicology / TDM	07/08/2005
Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device
K050050	Cannabinoids (THC)	Toxicology / TDM	07/08/2005
Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device
K050050	Phencyclidine (PCP)	Toxicology / TDM	07/08/2005
Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device
K050050	Cocaine Metabolites	Toxicology / TDM	07/08/2005
Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device
K050050	Opiates	Toxicology / TDM	07/08/2005
Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device
K050050	Methamphetamines	Toxicology / TDM	07/08/2005
Acon Laboratories, Inc. On Call Home Drug Test for Marijuana
K050936	Cannabinoids (THC)	Toxicology / TDM	06/30/2005
Acon Laboratories, Inc. On Call Home Drug Test for Marijuana and Cocaine
K050936	Cannabinoids (THC)	Toxicology / TDM	06/30/2005
Acon Laboratories, Inc. On Call Home Drug Test for Marijuana and Cocaine
K050936	Cocaine Metabolites	Toxicology / TDM	06/30/2005
TheraSense FreeStyle 600 Blood Glucose Monitoring System
K050500	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/30/2005
Metrika INViEW MULTI-TEST A1C MONITOR  (For OTC use)
K051321	Glycated Hemoglobin, Total	General Chemistry	06/15/2005
Metrika INViEW MULTI-TEST A1C MONITOR  (For professional use)
K051321	Glycated Hemoglobin, Total	General Chemistry	06/15/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup
K050878	Amphetamines	Toxicology / TDM	06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup
K050878	Cannabinoids (THC)	Toxicology / TDM	06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup
K050878	Phencyclidine (PCP)	Toxicology / TDM	06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup
K050878	Cocaine Metabolites	Toxicology / TDM	06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup
K050878	Opiates	Toxicology / TDM	06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup
K050878	Methamphetamine/Amphetamine	Toxicology / TDM	06/10/2005
Bioscreen Medical One Step Cassette Style hCG Urine (Home) Pregnancy Test
K050305	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/10/2005
Bioscreen Medical One Step hCG Pregnancy Urine Test Cassette
K050305	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/10/2005
Bioscreen Medical One Step hCG Pregnancy Urine Test Strip
K050305	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/10/2005
Bioscreen Medical One Step hCG Pregnancy Urine/Serum Test Cassette
K050305	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/10/2005
Bioscreen Medical One Step hCG Pregnancy Urine/Serum Test Strip
K050305	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/10/2005
Bioscreen Medical One Step Midstream Style hCG Urine (Home) Pregnancy Test
K050305	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/10/2005
Bioscreen Medical One Step Strip Style hCG Urine (Home) Pregnancy Test
K050305	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/10/2005
Wampole Laboratories Clearview hCG Combo
K992187	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/10/2005
Wampole Laboratories Clearview hCG Combo with Reference Line
K992187	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/10/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (Professional Use)
K050050	Amphetamines	Toxicology / TDM	06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (Professional Use)
K050050	Cannabinoids (THC)	Toxicology / TDM	06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (Professional Use)
K050050	Phencyclidine (PCP)	Toxicology / TDM	06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (Professional Use)
K050050	Cocaine Metabolites	Toxicology / TDM	06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (Professional Use)
K050050	Opiates	Toxicology / TDM	06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (Professional Use)
K050050	Methamphetamines	Toxicology / TDM	06/03/2005
Home Diagnostics, Aurora Pharmacy TrueTrack Smart System Blood Glucose System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/03/2005
Home Diagnostics, Closer Care TrueTrack Smart System Blood Glucose System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/03/2005
LifesScan OneTouch InDuo Blood Glucose Monitoring System
K043197	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/03/2005
LifesScan OneTouch Ultra Blood Glucose Monitoring System
K043197	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/03/2005
LifesScan OneTouch UltrasSmart Blood Glucose Monitoring System
K043197	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/03/2005
McKesson Corporation Medi-Lab Performance hCG Combo - Cassette
K992187	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/03/2005
McKesson Corporation Medi-Lab Performance hCG Urine - Dipstick
K954444	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/03/2005
VIP Diagnostics LLC EZ Smart Blood Glucose Monitoring System
K043340	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/03/2005
Wampole Laboratories Clearview hCG II (Dipstick)
K954444	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/03/2005
Acon +/- Pregnancy Test
K050546	hCG, Urine	Endocrinology	05/23/2005
Pfizer e.p.t Certainty Pregnancy Test
K050930	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/19/2005
Wampole Laboratories Clearview LH Ovulation Test
K924903	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	05/18/2005
IND Diagnostic One Step hCG Pregnancy Test - Cassette Format
K050741	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/12/2005
Roche Diagnostics Accu-Chek Integra Blood Glucose Monitoring System
K050872	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/05/2005
ROCHE DIAGNOSTICS CORP. ACCU-CHEK Aviva System
K043474	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/02/2005
RAC Medical Clarity HCG Combo Cassettes
K974009	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/28/2005
RAC Medical Clarity HCG Urine Cassettes
K023638	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/28/2005
RAC Medical Clarity Ketone Urine Reagent Strips For Urinalysis
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis
K993850	Urine Qualitative Dipstick Bilirubin	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis
K993850	Urine Qualitative Dipstick Blood	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis
K993850	Urine Qualitative Dipstick Ph	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis
K993850	Urine Qualitative Dipstick Protein	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis
K993850	Urine Qualitative Dipstick Urobilinogen	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek 10 SG Urine Reagent Strips For Urinalysis
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek US-4 OB
K993850	Urine Qualitative Dipstick Blood	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek US-4 OB
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek US-4 OB
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	04/28/2005
RAC Medical Clarity Multistrip Urochek US-4 OB
K993850	Urine Qualitative Dipstick Protein	Urinalysis	04/28/2005
EPS Bio Technology Easy Pain Supreme Blood Glucose Monitoring System
K043245	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/27/2005
RAC Medical Clarity Multistrip Urochek US-2 GP Reactive Strip For Urine Detection of 2 Parameters
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	04/27/2005
RAC Medical Clarity Multistrip Urochek US-2 GP Reactive Strip For Urine Detection of 2 Parameters
K993850	Urine Qualitative Dipstick Protein	Urinalysis	04/27/2005
Mizuho USA Proof Positive Electronic Pregnancy Test
K043231	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/26/2005
PerMaxim RadiScreen H. pylori Test Device  (Whole Blood)
K024350	Helicobacter Pylori Antibodies	General Immunology	04/26/2005
RAC Medical Clarity hCG Urine Strips
K951705	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/26/2005
ReliaLAB Inc. InstaRead Lithium System  (fingerstick or venipuncture whole blood)
K031579	Lithium	Toxicology / TDM	04/22/2005
Biotechnostix Rapid Response Strep A Rapid Test Device
K023766	Streptococcus, Group A	Bacteriology	04/21/2005
Biotechnostix Rapid Response Strep A Rapid Test Strip
K010582	Streptococcus, Group A	Bacteriology	04/21/2005
RAC Medical Clarity Strep A Rapid Test Strips
K010582	Streptococcus, Group A	Bacteriology	04/21/2005
RAC Medical Clarity Strep A Twist Rapid Test Device
K023766	Streptococcus, Group A	Bacteriology	04/21/2005
US Diagnostics, Inc. EASYGLUCO Blood Monitoring System
K043512	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/21/2005
US Diagnostics, Inc. Freedom Blood Glucose Monitoring System
K043543	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/20/2005
Genzyme Corporation OSOM hCG Combo Test
K043385	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/18/2005
Wampole Laboratories Clearview RSV
K021789	Respiratory Syncytial Virus	Virology	04/11/2005
Wondfo One Step HCG Urine Pregnancy Test
K043443	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/08/2005
AFW Alliance Health Care America TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Albertson's Inc. Sav-On Osco By Albertson's TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
AmerisourceBergen Brite-Life TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
AmerisourceBergen Good Neighbor Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Brooks Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Cardinal Health Leader TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Cardinal Health Your 1st Choice For Value! TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Chain Drug Consortium, LLC Premier Value TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Clarity Hemosure One-Step Immunological Fecal Occult Blood Test
K041202	Fecal Occult Blood	General Chemistry	03/30/2005
CVS Pharmacy Inc. Blood Glucose Monitor, TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Eckerd Drug Company TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Family Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
H-E-B inControl Plus Complete Diabetes Monitoring Kit, TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Home Diagnostics Inc. Navarro TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Home Diagnostics, Inc. Discount Drug Mart Food Fair TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Home Diagnostics, TrackEASE Smart System Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Kmart Corp. American Fare TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Longs Drugs Glucose Monitor TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
McKesson Corporation SunMark Performance Plus Blood Glucose Monitoring System, TrueTrack Smart System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
McKesson Sunmark TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Medicine Shoppe International TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Meijer Distribution Inc. Blood Glucose Monitor, TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Preferred Plus Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Walgreens Blood Glucose Monitor, TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Winn-Dixie Stores Inc. (WD) TrueTrack Smart System, Blood Glucose Monitoring System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/30/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Leukocytes	Urinalysis	03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Ketone	Urinalysis	03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Bilirubin	Urinalysis	03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Blood	Urinalysis	03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Glucose	Urinalysis	03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Nitrite	Urinalysis	03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Ph	Urinalysis	03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Protein	Urinalysis	03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Urobilinogen	Urinalysis	03/29/2005
Saless Enterprises Inc. New Choice Urinalysis Reagent Strips (10 parameters)
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	03/29/2005
Polymer Technology Systems Cardiochek Brand Analyzer
K040693	LDL Cholesterol	General Chemistry	03/25/2005
Polymer Technology Systems CardioChek PA Analyzer
K040693	LDL Cholesterol	General Chemistry	03/25/2005
Accumetrics VerifyNow-Aspirin Assay
K042423	Platelet Aggregation	Hematology	03/22/2005
PerMaxim, RediScreen-Ultra Fecal Occult Blood Test
K902360	Fecal Occult Blood	General Chemistry	03/17/2005
ACON Laboratories, On Call Multi-Drug Home Test
K050050	Amphetamines	Toxicology / TDM	03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test
K050050	Cannabinoids (THC)	Toxicology / TDM	03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test
K050050	Phencyclidine (PCP)	Toxicology / TDM	03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test
K050050	Cocaine Metabolites	Toxicology / TDM	03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test
K050050	Opiates	Toxicology / TDM	03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test
K050050	Methamphetamines	Toxicology / TDM	03/16/2005
GENZYME OSOM TRICHOMONAS RAPID TEST
K033864	Trichomonas	Parasitology	03/16/2005
Home Diagnostics Diabetics Experts Of America Blood Glucose System
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/16/2005
Home Diagnostics, Equaline TrueTrack Smart System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/16/2005
Home Diagnostics, Publix TrueTrack Smart System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/16/2005
Home Diagnostics, Safeway TrueTrack Smart System
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/16/2005
Instant Technologies Inc. One Step hCG Pregnancy Urine Test Cassette
K023638	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/16/2005
Instant Technologies, Inc. One Step hCG Pregnancy Urine Test Strip
K951705	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/16/2005
McKesson Medi-Lab Performance Infectious Mononucleosis Test
K973559	Infectious Mononucleosis Antibodies (Mono)	General Immunology	03/16/2005
Saless Enterprises Inc. One Step hCG Pregnancy Urine Test Strip
K951705	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/16/2005
Saless Enterprises Inc. One Step hCG Pregnancy Urine Test Cassette
K023638	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/16/2005
Hypoguard Advance Micro-Draw Blood Glucose Monitoring System
K020232	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/10/2005
Howard Medical Company OneStep Pregnancy
K980531	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/09/2005
Matrix Distributors, Inc. NexGen Blood Glucose Monitoring System
K031388	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/09/2005
Inverness Medical, Clearview Mono-plus II
K973559	Infectious Mononucleosis Antibodies (Mono)	General Immunology	03/08/2005
MCKESSON MEDI-LAB PERFORMANCE STREP A TEST DIPSTICK
K033855	Streptococcus, Group A	Bacteriology	03/08/2005
Taidoc Clever Chek TD-3213 Blood Glucose and Blood Pressure Measurement System
K042795	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/08/2005
WAMPOLE LABORATORIES CLEARVIEW H. PYLORI II  (finger stick or whole blood)
K990892	Helicobacter Pylori Antibodies	General Immunology	03/08/2005
Common Sense Ltd. VI-SENSE Acidity Test Kit
K043109	Vaginal pH	General Chemistry	03/07/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Ketone	Urinalysis	03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Bilirubin	Urinalysis	03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Blood	Urinalysis	03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Glucose	Urinalysis	03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Leukocytes	Urinalysis	03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Nitrite	Urinalysis	03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Ph	Urinalysis	03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Protein	Urinalysis	03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Urobilinogen	Urinalysis	03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Specific Gravity	Urinalysis	03/02/2005
Permaxim, LLC Rediscreen Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Ketone	Urinalysis	03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Bilirubin	Urinalysis	03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Blood	Urinalysis	03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Glucose	Urinalysis	03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Leukocytes	Urinalysis	03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Nitrite	Urinalysis	03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Ph	Urinalysis	03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Protein	Urinalysis	03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Urobilinogen	Urinalysis	03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Specific Gravity	Urinalysis	03/02/2005
Redwood Biotech, Inc. Urinalysis Reagent Strips  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	03/02/2005
Access Bio Inc. CareStart PLUS Pregnancy Test
K032159	hCG, Urine	Endocrinology	02/28/2005
Access Bio Inc. CareStart Pregnancy Test
K032159	hCG, Urine	Endocrinology	02/28/2005
ALFA SCIENTIFIC DESIGNS - ISCREEN FECAL OCCULT BLOOD TEST
K021423	Fecal Occult Blood	General Chemistry	02/25/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer
K980047	Urine Qualitative Dipstick Ketone	Urinalysis	02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer
K980047	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer
K980047	Urine Qualitative Dipstick Blood	Urinalysis	02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer
K980047	Urine Qualitative Dipstick Glucose	Urinalysis	02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer
K980047	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer
K980047	Urine Qualitative Dipstick Nitrite	Urinalysis	02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer
K980047	Urine Qualitative Dipstick Ph	Urinalysis	02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer
K980047	Urine Qualitative Dipstick Protein	Urinalysis	02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer
K980047	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer
K980047	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/18/2005
DE Healthcare Products TruView hCG Pregnancy Test
K954444	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/18/2005
Henry Schein One Step+ hCG Strip Test
K954444	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/18/2005
Henry Schein One Step+ hCG Test
K953988	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer
K980047	Urine Qualitative Dipstick Ketone	Urinalysis	02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer
K980047	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer
K980047	Urine Qualitative Dipstick Blood	Urinalysis	02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer
K980047	Urine Qualitative Dipstick Glucose	Urinalysis	02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer
K980047	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer
K980047	Urine Qualitative Dipstick Nitrite	Urinalysis	02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer
K980047	Urine Qualitative Dipstick Ph	Urinalysis	02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer
K980047	Urine Qualitative Dipstick Protein	Urinalysis	02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer
K980047	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/18/2005
Physician Sales & Services, Inc. PSS Select Urine Analyzer
K980047	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/18/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE
K040629	Amphetamines	Toxicology / TDM	02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE
K040629	Cannabinoids (THC)	Toxicology / TDM	02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE
K040629	Phencyclidine (PCP)	Toxicology / TDM	02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE
K040629	Cocaine Metabolites	Toxicology / TDM	02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE
K040629	Opiates	Toxicology / TDM	02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE
K040629	Methamphetamines	Toxicology / TDM	02/17/2005
DE Healthcare Products TruView hCG Combo Pregnancy Cassette Test
K992187	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/17/2005
DE Healthcare Products TruView hCG Pregnancy Cassette Test
K953988	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/17/2005
Henry Schein One Step+ hCG Combo Test
K992187	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/17/2005
VIP International Wholesalers, Corp. Ez Smart Blood Glucose Monitoring System
K040848	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/17/2005
ACON SPECTRUM MIDSTREAM PREGNANCY TEST
K042151	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/15/2005
HOME DIAGNOSTICS INVACARE QUALITY ALTERNATIVES BLOOD GLUCOSE MONITOR - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/15/2005
HOME DIAGNOSTICS MCKESSON SUNMARK PERFORMANCE BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/15/2005
HOME DIAGNOSTICS MP TOTAL CARE BLOOD GLUCOSE TEST STRIPS - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/15/2005
HOME DIAGNOSTICS NATIONAL RURAL ELECTRIC COOPERATIVE ASSOCIATION BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/15/2005
HOME DIAGNOSTICS STAR MEDICAL BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/15/2005
Immunostics Immuno hCG Detector
K041728	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/15/2005
Immunostics Immuno hCG Detector Combi
K041728	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/15/2005
Immunostics Immuno hCG Detector Stix Test
K041728	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/15/2005
NEO DIAGNOSTICS INC. KETOCHECKS
K033114	Urine Qualitative Dipstick Ketone	Urinalysis	02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)
K041578	Amphetamines	Toxicology / TDM	02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)
K041578	Cannabinoids (THC)	Toxicology / TDM	02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)
K041578	Phencyclidine (PCP)	Toxicology / TDM	02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)
K041578	Cocaine Metabolites	Toxicology / TDM	02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9177X)
K041578	Opiates	Toxicology / TDM	02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)
K041578	Amphetamines	Toxicology / TDM	02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)
K041578	Cannabinoids (THC)	Toxicology / TDM	02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)
K041578	Cocaine Metabolites	Toxicology / TDM	02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)
K041578	Opiates	Toxicology / TDM	02/15/2005
PHAMATECH QUICKSCREEN (MODEL 9178X)
K041578	Methamphetamines	Toxicology / TDM	02/15/2005
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS CHOL+GLU TEST PANEL}
K041750	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/15/2005
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS CHOL+GLU TEST PANEL}
K041750	Cholesterol	General Chemistry	02/15/2005
Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+GLU TEST PANEL}
K041750	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/15/2005
Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+GLU TEST PANEL}
K041750	Cholesterol	General Chemistry	02/15/2005
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+GLU TEST PANEL}
K041750	Cholesterol	General Chemistry	02/15/2005
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+GLU TEST PANEL} (Professional Use)
K041750	Glucose	General Chemistry	02/15/2005
AZOG One Step hCG Home Pregnacy Test Device (Urine)
K041748	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/14/2005
AZOG One Step hCG Home Pregnacy Test Strip (Urine)
K041748	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/14/2005
AZOG One Step hCG Pregnacy Test Midstream (Urine)
K041748	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/14/2005
BAYER RELI-ON KETONE TEST STRIPS
K801270	Ketone, Urine	General Chemistry	02/14/2005
Cardinal Health SP Brand Rapid Test hCG Cassette
K953988	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/04/2005
Cardinal Health SP Brand Rapid Test hCG Combo
K992187	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/04/2005
Cardinal Health SP Brand Rapid Test hCG Dipstick
K954444	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/04/2005
ALFA SCIENTIFIC DESIGNS INSTANT VIEW H. PYLORI WHOLE BLOOD RAPID TEST
K024360	Helicobacter Pylori Antibodies	General Immunology	02/01/2005
DIAGNOSTIC DEVICES INC. GLUCOCHECK BLOOD GLUCOSE MONITORING SYSTEM
K032029	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/01/2005
Binax NOW RSV Test
K032166	Respiratory Syncytial Virus	Virology	01/28/2005
INVERNESS MEDICAL SIGNIFY HCG CARD PREGNANCY TEST
K953988	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/27/2005
INVERNESS MEDICAL SIGNIFY HCG URINE/SERUM PREGNANCY TEST
K992187	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/27/2005
INVERNESS MEDICAL SIGNIFY HCG-URINE PREGNANCY TEST
K954444	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/27/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test
K022355	Amphetamines	Toxicology / TDM	01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test
K022355	Cannabinoids (THC)	Toxicology / TDM	01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test
K022355	Phencyclidine (PCP)	Toxicology / TDM	01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test
K022355	Cocaine Metabolites	Toxicology / TDM	01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test
K022355	Opiates	Toxicology / TDM	01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test
K022355	Methadone	Toxicology / TDM	01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test
K022355	Methamphetamines	Toxicology / TDM	01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test
K022355	Benzodiazepines	Toxicology / TDM	01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test
K022355	Barbiturates	Toxicology / TDM	01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test
K022355	Tricyclic Antidepressants	Toxicology / TDM	01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test
K022355	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test
K022355	Oxycodone	Toxicology / TDM	01/26/2005
Cardinal Health SP Brand Rapid Test Strep A Dipstick
K033855	Streptococcus, Group A	Bacteriology	01/25/2005
Beckman Coulter, ICON Mono
X040027	Infectious Mononucleosis Antibodies (Mono)	General Immunology	01/24/2005
PRINCETON BIOMEDITECH STATUS FIRST STREP A
K040708	Streptococcus, Group A	Bacteriology	01/19/2005
Cardinal Health SP Brand Rapid Test H. Pylori
K990892	Helicobacter Pylori Antibodies	General Immunology	01/13/2005
CENOGENICS CHEMVIEW-10
K042641	Urine Qualitative Dipstick Ketone	Urinalysis	01/13/2005
CENOGENICS CHEMVIEW-10
K042641	Urine Qualitative Dipstick Bilirubin	Urinalysis	01/13/2005
CENOGENICS CHEMVIEW-10
K042641	Urine Qualitative Dipstick Blood	Urinalysis	01/13/2005
CENOGENICS CHEMVIEW-10
K042641	Urine Qualitative Dipstick Glucose	Urinalysis	01/13/2005
CENOGENICS CHEMVIEW-10
K042641	Urine Qualitative Dipstick Leukocytes	Urinalysis	01/13/2005
CENOGENICS CHEMVIEW-10
K042641	Urine Qualitative Dipstick Nitrite	Urinalysis	01/13/2005
CENOGENICS CHEMVIEW-10
K042641	Urine Qualitative Dipstick Ph	Urinalysis	01/13/2005
CENOGENICS CHEMVIEW-10
K042641	Urine Qualitative Dipstick Protein	Urinalysis	01/13/2005
CENOGENICS CHEMVIEW-10
K042641	Urine Qualitative Dipstick Urobilinogen	Urinalysis	01/13/2005
CENOGENICS CHEMVIEW-10
K042641	Urine Qualitative Dipstick Specific Gravity	Urinalysis	01/13/2005
Cardinal Health, SP Brand Rapid Test Mono
K973559	Infectious Mononucleosis Antibodies (Mono)	General Immunology	01/10/2005
Inverness Medical, Signify Mono Test
K973559	Infectious Mononucleosis Antibodies (Mono)	General Immunology	01/10/2005
Inverness Medical, Signify Strep A Dipstick
K033855	Streptococcus, Group A	Bacteriology	01/10/2005
Bionime Corporation Rightest Blood Glucose Monitoring System
K042678	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/06/2005
BAYER DIAGNOSTICS ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
K043158	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/29/2004
BAYER DIAGNOSTICS ASCENSIA ELITE DIABETES CARE SYSTEM
K043311	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/29/2004
DYNAMIC DIAGNOSTICS INC. ONEPLUS PREGNANCY
K981165	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/29/2004
HOWARD MEDICAL COMPANY ONESTEP PLUS PREGNANCY
K981165	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/29/2004
BIOSAFE LABORTORIES, INC., ANEMIAPRO SELF SCREENER
K042379	Hemoglobin	Hematology	12/22/2004
TAIDOC SWIFT CHEK BLOOD GLUCOSE MONITORING SYSTEM
K042005	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/22/2004
GERMAINE LABORATORIES, AIMSTEP H. PYLORI  (Whole Blood)
K024350	Helicobacter Pylori Antibodies	General Immunology	12/09/2004
HENRY SCHEIN ONE STEP+ MONO TEST
K973559	Infectious Mononucleosis Antibodies (Mono)	General Immunology	12/09/2004
HOME DIAGNOSTICS, CAREONE TRUETRACK SMART SYSTEM
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/09/2004
HOME DIAGNOSTICS, DUANE READE TRUE TRACK SMART SYSTEM
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/09/2004
HOME DIAGNOSTICS, FASA BLOOD GLUCOSE MONITORING SYSTEM (PRESTIGE SMART SYSTEM IQ)
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/09/2004
HOME DIAGNOSTICS, INVACARE TRUETRACK SMART SYSTEM
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/09/2004
HOME DIAGNOSTICS, MMM MEDICARE Y MUCHA MAS BLOOD GLUCOSE MONITORING SYSTEM (PRESTIGE SMART SYSTEM IQ)
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/09/2004
HOME DIAGNOSTICS, MOLINA HEALTHCARE TRUETRACK SMART SYSTEM
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/09/2004
BinaxNOW Influenza A & B Test  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens)
K041049	Influenza A/B	Virology	12/01/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Ketone	Urinalysis	11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Bilirubin	Urinalysis	11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Blood	Urinalysis	11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Glucose	Urinalysis	11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Leukocytes	Urinalysis	11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Nitrite	Urinalysis	11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Ph	Urinalysis	11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Protein	Urinalysis	11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Urobilinogen	Urinalysis	11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Specific Gravity	Urinalysis	11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	11/17/2004
PROVALIS DIAGNOSTICS IN2IT IN-OFFICE ANALYZER (II) A1C PRESCRIPTION HOME USE TEST SYSTEM
K041635	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	11/09/2004
TRINITY BIOTECH UNI-GOLD RECOMBIGEN HIV TEST  (Fingerstick, Venipuncture Whole Blood)
BP030025	HIV-1 Antibody	General Immunology	11/05/2004
BECKMAN COULTER ICON DS STREP A
K983386	Streptococcus, Group A	Bacteriology	10/29/2004
BECKMAN COULTER, INC. ICON 20 HCG SERUM/URINE TEST
K020439	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/29/2004
DE HEALTHCARE PRODUCTS TRUVIEW H. PYLORI TEST
K990892	Helicobacter Pylori Antibodies	General Immunology	10/29/2004
DE HEALTHCARE PRODUCTS TRUVIEW STREP A DIPSTICK TEST
K033855	Streptococcus, Group A	Bacteriology	10/29/2004
Henry Schein One Step+ Strep A Dipstick Test
K033855	Streptococcus, Group A	Bacteriology	10/29/2004
HENRY SCHEIN ONESTEP+ H. PYLORI TEST
K990892	Helicobacter Pylori Antibodies	General Immunology	10/29/2004
LABORATORY SUPPLY COMPANY (LSC) PEP STREP A CASSETTE TEST
K023766	Streptococcus, Group A	Bacteriology	10/29/2004
LABORATORY SUPPLY COMPANY (LSC) PEP STREP A DIPSTICK TEST
K010582	Streptococcus, Group A	Bacteriology	10/29/2004
STANBIO LABORATORY EZ-WELL STREP A RAPID DEVICE TEST
K023766	Streptococcus, Group A	Bacteriology	10/29/2004
CHURCH & DWIGHT CO., INC. FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
K040866	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/22/2004
CEN-MED Elite Plus One-Step Pregnancy Test (Urine Or Serum)
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/19/2004
APPLIED BIOTECH ONE STEP+ MONO TEST
K973559	Infectious Mononucleosis Antibodies (Mono)	General Immunology	10/15/2004
APPLIED BIOTECH TRUVIEW MONO TEST
K973559	Infectious Mononucleosis Antibodies (Mono)	General Immunology	10/15/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER
K980047	Urine Qualitative Dipstick Ketone	Urinalysis	09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER
K980047	Urine Qualitative Dipstick Bilirubin	Urinalysis	09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER
K980047	Urine Qualitative Dipstick Blood	Urinalysis	09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER
K980047	Urine Qualitative Dipstick Glucose	Urinalysis	09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER
K980047	Urine Qualitative Dipstick Leukocytes	Urinalysis	09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER
K980047	Urine Qualitative Dipstick Nitrite	Urinalysis	09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER
K980047	Urine Qualitative Dipstick Ph	Urinalysis	09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER
K980047	Urine Qualitative Dipstick Protein	Urinalysis	09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER
K980047	Urine Qualitative Dipstick Urobilinogen	Urinalysis	09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER
K980047	Urine Qualitative Dipstick Specific Gravity	Urinalysis	09/27/2004
LABORATORY SUPPLY COMPANY (LSC) PEP HCG COMBO TEST
K041728	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/20/2004
LABORATORY SUPPLY COMPANY (LSC) PEP HCG STRIP TEST
K041728	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/20/2004
LABORATORY SUPPLY COMPANY (LSC) PEP HCG TEST
K041728	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/20/2004
Matrix Distributors, Inc. NexGen Blood Glucose Monitoring System
K020232	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/20/2004
PEP PERFORMANCE ENHANCED PRODUCTS STREP A CASSETTE TEST
K023766	Streptococcus, Group A	Bacteriology	09/16/2004
PEP PERFORMANCE ENHANCED PRODUCTS STREP A DIPSTICK
K010582	Streptococcus, Group A	Bacteriology	09/16/2004
UNIPATH DIAGNOSTICS FACT PLUS ONE-STEP PREGNANCY TEST
K042280	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/14/2004
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/10/2004
TAIDOC ACHTUNG TD-4207 GLUCOSE TEST SYSTEM
K042005	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/10/2004
TAIDOC CLEVER CHEK TD-4209 GLUCOSE TEST SYSTEM
K042005	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/10/2004
TAIDOC CLEVER CHEK TD-4222 GLUCOSE TEST SYSTEM
K042005	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/10/2004
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
K041202	Fecal Occult Blood	General Chemistry	09/08/2004
HYPOGUARD ADVANCE INTUITION BLOOD GLUCOSE MONITORING SYSTEM
K002621	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/01/2004
HOME DIAGNOSTICS, TRACKEASE SMART SYSTEM BLOOD GLUCOSE METER
K042080	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/27/2004
HYPOGUARD ADVANCE INTUITION BLOOD GLUCOSE MONITORING SYSTEM
K011233	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/27/2004
Hypoguard Advance Micro-Draw Blood Glucose Monitoring System
K031388	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/27/2004
BRISTOL-MYERS SQUIBB CO. CHOICE DM
K033847	Glycated Hemoglobin, Total	General Chemistry	08/26/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA (THC)
K040327	Cannabinoids (THC)	Toxicology / TDM	08/24/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA (THC) AND COCAINE (COC)
K040327	Cannabinoids (THC)	Toxicology / TDM	08/24/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA (THC) AND COCAINE (COC)
K040327	Cocaine Metabolites	Toxicology / TDM	08/24/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE
K041221	Amphetamines	Toxicology / TDM	08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE
K041221	Cannabinoids (THC)	Toxicology / TDM	08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE
K041221	Phencyclidine (PCP)	Toxicology / TDM	08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE
K041221	Cocaine Metabolites	Toxicology / TDM	08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE
K041221	Opiates	Toxicology / TDM	08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE
K041221	Methamphetamines	Toxicology / TDM	08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE
K041221	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	08/19/2004
Clearview Ultra FOB Test
K041297	Fecal Occult Blood	General Chemistry	08/18/2004
Eumed Biotechnology Co. Eusure Blood Glucose Monitoring System
K040678	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/18/2004
POLYMEDCO POLY STAT OC-LIGHT FOB TEST
K041297	Fecal Occult Blood	General Chemistry	08/18/2004
PROVALIS DIAGNOSTICS G5 II HBA1C TEST SYSTEM
K041635	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	08/18/2004
THYROTEC INC. THYROTEST WHOLE BLOOD TSH TEST
K030912	Thyroid Stimulating Hormone (TSH)	Endocrinology	08/18/2004
Apex Biotechnology Corporation {Hypoguard Assure 3 Blood Glucose Monitoring System}
K011233	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/05/2004
Apex Biotechnology Corporation {Hypoguard Assure 3 Blood Glucose Monitoring System}
K002621	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/29/2004
APPLIED BIOTECH SURESTEP EXACT STREP A TEST
K033855	Streptococcus, Group A	Bacteriology	07/26/2004
GENZYME OSOM ULTRA STREP A TEST
K992658	Streptococcus, Group A	Bacteriology	07/15/2004
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023639	Triglyceride	General Chemistry	07/09/2004
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023640	HDL Cholesterol	General Chemistry	07/09/2004
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023642	Cholesterol	General Chemistry	07/09/2004
HEMOCUE HB 201+SYSTEM  (CAPILLARY, VENOUS, ARTERIAL WHOLE BLOOD)
K032203	HGB, SINGLE ANALYTE INST. W/SELF-CONT...	Hematology	06/30/2004
ACON LABORATORIES, INC. FSH MENOPAUSE PREDICTOR TEST
K041165	Follicle Stimulating Hormone (FSH)	Endocrinology	06/28/2004
BECKMAN COULTER HEMOCCULT ICT
K961062	Fecal Occult Blood	General Chemistry	06/28/2004
CHASMA SCIENTIFIC, INC., CHASMA-CULT {TRI-SLIDE AND SINGLE SLIDE STOOL}
K761232	Fecal Occult Blood	General Chemistry	06/28/2004
CHASMA SCIENTIFIC, INC., CHASMA-CULT {QUICK CULT SLIDE}
K761232	Fecal Occult Blood	General Chemistry	06/28/2004
HEMOCUE HB 201 DM ANALYZING SYSTEM
K041234	Hemoglobin	Hematology	06/28/2004
IMMUNOSTICS DETECTOR STREP A DIRECT
K023766	Streptococcus, Group A	Bacteriology	06/28/2004
JANT PHARMACAL CORP CLINIPAK STREP A RAPID TEST STRIP
K010582	Streptococcus, Group A	Bacteriology	06/28/2004
UNIPATH DIAGNOSTICS CLEARBLUE EASY EASY READ PREGNANCY TEST
K041404	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/28/2004
ORASURE ORAQUICK ADVANCE RAPID HIV-1/2 ANTIBODY TEST  (ORAL FLUID, FINGERSTICK WHOLE BLOOD AND VENIPUNCTURE WHOLE BLOOD)
BP010047	HIV-1 and HIV-2 Antibodies	General Immunology	06/25/2004
BECKMAN COULTER ICON II HCG  (urine/serum)
K860542	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/23/2004
TAIDOC CHECK GLUCOSE TEST SYSTEM
K041107	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/23/2004
TRINITY BIOTECH UNI-GOLD RECOMBIGEN HIV TEST  (WHOLE BLOOD (VENIPUNCTURE))
BP030025	HIV-1 Antibody	General Immunology	06/23/2004
BECKMAN COULTER ICON II HCG (URINE)
K865057	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/22/2004
CHOLESTECH L.D.X. {Whole Blood}
K032027	Aspartate Aminotransferase (AST) (SGOT)	General Chemistry	06/18/2004
Stanbio HemoPoint H2 Hemoglobin Measurement System
K032482	Hemoglobin	Hematology	06/09/2004
W.H.P.M. ONE-STEP PREGNANCY TEST
K041273	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/08/2004
TOTAL DIAGNOSTIC SALES, INC. TEST TIME HOME GLUCOSE TEST
K943503	Glucose	General Chemistry	06/07/2004
POLYMEDCO POLY STAT STREP A LIQUID TEST
K021375	Streptococcus, Group A	Bacteriology	06/04/2004
LIFESTREAM TECHNOLOGIES LIFESTREAM PLUS CHOLESTEROL MONITOR
K033899	Cholesterol	General Chemistry	06/02/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
K040629	Cannabinoids (THC)	Toxicology / TDM	05/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
K040629	Phencyclidine (PCP)	Toxicology / TDM	05/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
K040629	Cocaine Metabolites	Toxicology / TDM	05/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
K040629	Opiates	Toxicology / TDM	05/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
K040629	Methamphetamines	Toxicology / TDM	05/26/2004
ACCU-STAT HOME MULTI-DRUG TEST
K040629	Amphetamines	Toxicology / TDM	05/26/2004
BECKMAN COULTER HEMOCCULT ICT
K961062	Fecal Occult Blood	General Chemistry	05/26/2004
PHAMATECH MOMENTS MENOPAUSE CHECK
K040575	Follicle Stimulating Hormone (FSH)	Endocrinology	05/26/2004
Becton Dickinson, Paradigm Link Blood Glucose Monitor
K040603	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/19/2004
APPLIED BIOTECH INSTACHECK FSH TEST  (Professional Use)
K023408	Follicle Stimulating Hormone (FSH)	Endocrinology	05/11/2004
SYNOVA HEALTHCARE MENOCHECKPRO  (Professional Use)
K023408	Follicle Stimulating Hormone (FSH)	Endocrinology	05/11/2004
HEMOCUE HEMOGLOBIN 201 + / HEMOCUE HEMOGLOBIN MICROCUVETTE SYSTEM
K032203	HGB, SINGLE ANALYTE INST. W/SELF-CONT...	Hematology	05/04/2004
QUIDEL QUICKVUE ADVANCE PH AND AMINES TEST
K040008	Vaginal pH	General Chemistry	05/03/2004
QUIDEL QUICKVUE ADVANCE PH AND AMINES TEST
K040008	Amines	General Chemistry	05/03/2004
JANT PHARMACAL CLINIPAK HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/27/2004
JANT PHARMACAL CLINIPAK HCG ONE STEP PREGNANCY TEST DEVICE (URINE/SERUM)
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/27/2004
JANT PHARMACAL CLINIPAK HCG ONE STEP PREGNANCY TEST STRIP (URINE)
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/27/2004
JANT PHARMACAL CLINIPAK HCG ONE STEP PREGNANCY TEST STRIP (URINE/SERUM)
K980736	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/27/2004
Roche Diagnostics Accu-Chek Go Blood Glucose Monitoring System
K040796	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA (THC)
K040327	Cannabinoids (THC)	Toxicology / TDM	04/22/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA (THC) AND COCAINE (COC)
K040327	Cannabinoids (THC)	Toxicology / TDM	04/22/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA (THC) AND COCAINE (COC)
K040327	Cocaine Metabolites	Toxicology / TDM	04/22/2004
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/15/2004
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814	Ketone, Blood	General Chemistry	04/15/2004
DE HEALTHCARE PRODUCTS TRUVIEW STREP A TEST
K023766	Streptococcus, Group A	Bacteriology	04/15/2004
AERSCHER HEMAPROMPT
K031356	Gastric Occult Blood	General Chemistry	04/07/2004
AERSCHER HEMAPROMPT FG
K972763	Fecal Occult Blood	General Chemistry	04/07/2004
ACON ONE STEP OVULATION TEST DEVICE (URINE)
X030003	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	04/05/2004
MEDISENSE PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
K040628	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/26/2004
HOME DIAGNOSTICS, TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER
K032657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/25/2004
IND DIAGNOSTIC ONE STEP LH OVULATION TEST
K040626	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	03/25/2004
Acon Helicobacter Pylori Rapid Test Device
K024350	Helicobacter Pylori	Bacteriology	03/23/2004
UNIPATH DIAGNOSTICS CLEARBLUE EASY DIGITAL OVULATION TEST
X040028	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	03/23/2004
UNIPATH DIAGNOSTICS CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
K040341	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/11/2004
PFIZER CONSUMER HEALTHCARE E.P.T. PREGNANCY TEST
K040329	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/08/2004
HYPOGUARD DIASCREEN REAGENT STRIPS FOR URINALYSIS GLUCOSE/KETONES  (Over-The-Counter)
K033851	Urine Qualitative Dipstick Ketone	Urinalysis	03/02/2004
HYPOGUARD DIASCREEN REAGENT STRIPS FOR URINALYSIS GLUCOSE/KETONES  (Over-The-Counter)
K033851	Urine Qualitative Dipstick Glucose	Urinalysis	03/02/2004
Apex Biotechnology Corporation {HYPOGUARD ADVANCE INTUITION BLOOD GLUCOSE MONITORING SYSTEM}
K002621	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/26/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD
K023712	Cannabinoids (THC)	Toxicology / TDM	02/24/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD
K023712	Phencyclidine (PCP)	Toxicology / TDM	02/24/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD
K023712	Cocaine Metabolites	Toxicology / TDM	02/24/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD
K023712	Opiates	Toxicology / TDM	02/24/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD
K023712	Methamphetamines	Toxicology / TDM	02/24/2004
HEMOCARE
K840527	Fecal Occult Blood	General Chemistry	02/23/2004
SYNOVA HEALTHCARE MENOCHECK MENOPAUSE INDICATOR TEST
K023408	Follicle Stimulating Hormone (FSH)	Endocrinology	02/23/2004
HOME DIAGNOSTICS, BRITE-LIFE TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2004
HOME DIAGNOSTICS, BROOKS TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2004
HOME DIAGNOSTICS, DISCOUNT DRUG MART FOOD FAIR TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2004
HOME DIAGNOSTICS, HEALTH CARE AMERICA TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2004
HOME DIAGNOSTICS, NAVARRO TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2004
HOME DIAGNOSTICS, PREFERRED PLUS PHARMACY TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2004
HOME DIAGNOSTICS, WINN DIXIE (WD) TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/09/2004
Quidel QuickVue Influenza A+B Test
K031899	Influenza A	Virology	02/06/2004
Quidel QuickVue Influenza A+B Test
K031899	Influenza B	Virology	02/06/2004
SA SCIENTIFIC SAS STREP A  (direct from throat swab)
K023270	Streptococcus, Group A	Bacteriology	02/02/2004
PFIZER CONSUMER HEALTHCARE E.P.T. PREGNANCY TEST
K033658	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/20/2004
ABBOTT MEDISENSE PRECISION XCEED DIABETES MONITORING SYSTEM
K033845	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/09/2004
BT MEDICAL, BTG SMARTEST BLOOD GLUCOSE MONITORING SYSTEM
K032029	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/08/2004
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS
K991927	Urine Qualitative Dipstick Ketone	Urinalysis	12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS
K991927	Urine Qualitative Dipstick Bilirubin	Urinalysis	12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS
K991927	Urine Qualitative Dipstick Blood	Urinalysis	12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS
K991927	Urine Qualitative Dipstick Glucose	Urinalysis	12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS
K991927	Urine Qualitative Dipstick Leukocytes	Urinalysis	12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS
K991927	Urine Qualitative Dipstick Nitrite	Urinalysis	12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS
K991927	Urine Qualitative Dipstick Ph	Urinalysis	12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS
K991927	Urine Qualitative Dipstick Protein	Urinalysis	12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS
K991927	Urine Qualitative Dipstick Urobilinogen	Urinalysis	12/17/2003
PERMAXIM REDISCREEN URINALYSIS REAGENT STRIPS 10 PARAMETERS
K991927	Urine Qualitative Dipstick Specific Gravity	Urinalysis	12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10
K991927	Urine Qualitative Dipstick Ketone	Urinalysis	12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10
K991927	Urine Qualitative Dipstick Bilirubin	Urinalysis	12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10
K991927	Urine Qualitative Dipstick Blood	Urinalysis	12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10
K991927	Urine Qualitative Dipstick Glucose	Urinalysis	12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10
K991927	Urine Qualitative Dipstick Leukocytes	Urinalysis	12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10
K991927	Urine Qualitative Dipstick Nitrite	Urinalysis	12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10
K991927	Urine Qualitative Dipstick Ph	Urinalysis	12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10
K991927	Urine Qualitative Dipstick Protein	Urinalysis	12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10
K991927	Urine Qualitative Dipstick Urobilinogen	Urinalysis	12/17/2003
REDWOOD BIOTECH URINE REAGENT STRIPS-10
K991927	Urine Qualitative Dipstick Specific Gravity	Urinalysis	12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER
K033548	Urine Qualitative Dipstick Ketone	Urinalysis	12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER
K033548	Urine Qualitative Dipstick Bilirubin	Urinalysis	12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER
K033548	Urine Qualitative Dipstick Blood	Urinalysis	12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER
K033548	Urine Qualitative Dipstick Glucose	Urinalysis	12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER
K033548	Urine Qualitative Dipstick Leukocytes	Urinalysis	12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER
K033548	Urine Qualitative Dipstick Nitrite	Urinalysis	12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER
K033548	Urine Qualitative Dipstick Ph	Urinalysis	12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER
K033548	Urine Qualitative Dipstick Protein	Urinalysis	12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER
K033548	Urine Qualitative Dipstick Urobilinogen	Urinalysis	12/17/2003
ROCHE DIAGNOSTICS, URISYS 1100 URINE ANALYZER
K033548	Urine Qualitative Dipstick Specific Gravity	Urinalysis	12/17/2003
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
K033041	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/11/2003
BIOTECH ATLANTIC INC UNIMARK ONE STEP HOME PREGNANCY TEST DEVICE  (Cassette)
K032992	hCG, Urine	Endocrinology	12/09/2003
STANDARD DIAGNOSTICS GOOD MORNING TEST
K031798	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/09/2003
UNOTECH DIAGNOSTICS ACCUSTRIP HCG-COMBO MODEL, HCG-005
K032987	hCG, Urine	Endocrinology	12/09/2003
UNOTECH DIAGNOSTICS ACCUTEST HCG-COMBO MODEL,HCG-004
K032987	hCG, Urine	Endocrinology	12/09/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER
K032437	Urine Qualitative Dipstick Ketone	Urinalysis	12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER
K032437	Urine Qualitative Dipstick Bilirubin	Urinalysis	12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER
K032437	Urine Qualitative Dipstick Blood	Urinalysis	12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER
K032437	Urine Qualitative Dipstick Glucose	Urinalysis	12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER
K032437	Urine Qualitative Dipstick Leukocytes	Urinalysis	12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER
K032437	Urine Qualitative Dipstick Nitrite	Urinalysis	12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER
K032437	Urine Qualitative Dipstick Ph	Urinalysis	12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER
K032437	Urine Qualitative Dipstick Protein	Urinalysis	12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER
K032437	Urine Qualitative Dipstick Urobilinogen	Urinalysis	12/05/2003
ROCHE DIAGNOSTICS CHEMSTRIP 101 URINE ANALYZER
K032437	Urine Qualitative Dipstick Specific Gravity	Urinalysis	12/05/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER
K980047	Urine Qualitative Dipstick Ketone	Urinalysis	11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER
K980047	Urine Qualitative Dipstick Bilirubin	Urinalysis	11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER
K980047	Urine Qualitative Dipstick Blood	Urinalysis	11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER
K980047	Urine Qualitative Dipstick Glucose	Urinalysis	11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER
K980047	Urine Qualitative Dipstick Leukocytes	Urinalysis	11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER
K980047	Urine Qualitative Dipstick Nitrite	Urinalysis	11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER
K980047	Urine Qualitative Dipstick Ph	Urinalysis	11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER
K980047	Urine Qualitative Dipstick Protein	Urinalysis	11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER
K980047	Urine Qualitative Dipstick Urobilinogen	Urinalysis	11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER
K980047	Urine Qualitative Dipstick Specific Gravity	Urinalysis	11/25/2003
HOME DIAGNOSTICS, AMERICAN FARE TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/17/2003
HOME DIAGNOSTICS, ECKERD TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/17/2003
HOME DIAGNOSTICS, FAMILY PHARMACY TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/17/2003
HOME DIAGNOSTICS, GOOD NEIGHBOR PHARMACY TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/17/2003
HOME DIAGNOSTICS, HEB IN CONTROL PLUS BLOOD GLUCOSE SYSTEM, TRUETRACK SMART SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/17/2003
HOME DIAGNOSTICS, MCKESSON SUNMARK PERFORMANCE PLUS BLOOD GLUCOSE SYSTEM, TRUETRACK SMART SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/17/2003
HOME DIAGNOSTICS, PREMIER VALUE TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/17/2003
Home Diagnostics, TrackEASE Smart System Blood Glucose Monitoring System, Truetrack Smart System
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/17/2003
CONCEPTION TECHNOLOGIES ASSURE LH OVULATION PREDICTOR
K924903	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	11/06/2003
ACON ONE STEP OVULATION TEST STRIP (URINE)
X030004	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	11/05/2003
ACON QUIK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
K032661	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/05/2003
EKF DIAGNOSTIC HEMO_CONTROL MEASUREMENT AND HEMO_CONTROL MICROCUVETTES
K031898	Hemoglobin	Hematology	11/03/2003
AMERICAN HEALTHCARE EASYGLUCO BLOOD GLUCOSE TEST SYSTEM
K031501	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/28/2003
GENOSIS FERTELL FEMALE FERTILITY TEST
K032002	Follicle Stimulating Hormone (FSH)	Endocrinology	10/21/2003
GERMAINE LABORATORIES STREP AIM TOWER
K023766	Streptococcus, Group A	Bacteriology	10/21/2003
HMD BIOMEDICAL GLUCOLEADER ENHANCE BLOOD GLUCOSE MONITORING SYSTEM
K032985	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/21/2003
ENTERIX INSURE FECAL IMMUNOCHEMICAL TEST
K002457	Fecal Occult Blood	General Chemistry	10/16/2003
UNIPATH EPT CERTAINTY PREGNANCY TEST
K032939	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/15/2003
ORASURE TECHNOLOGIES ORAQUICK RAPID HIV-1 ANTIBODY TEST  (Fingerstick, Venipuncture Whole Blood)
BP010047	HIV-1 Antibody	General Immunology	09/30/2003
CHDIAGNOSTICS SENOVA BLOOD GLUCOSE MONITORING SYSTEM
K032076	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/29/2003
NEWTEK RELION BLOOD GLUCOSE MONITORING SYSTEM
K024347	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/29/2003
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS ICON SC STREP A TEST
K023766	Streptococcus, Group A	Bacteriology	09/25/2003
INSTANT TECHNOLOGIES ISTEP ONE STEP STREP A
K023766	Streptococcus, Group A	Bacteriology	09/25/2003
REDWOOD BIOTECH FECAL OCCULT BLOOD TEST
K902360	Fecal Occult Blood	General Chemistry	09/25/2003
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
K032510	hCG, Urine	Endocrinology	09/15/2003
ROCHE DIAGNOSTICS ACCU-CHEK ADVANTAGE III
K032552	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/10/2003
QUIDEL QUICKVUE+ ONE-STEP HCG COMBO
K973858	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/08/2003
INTEGRATED BIOTECHNOLOGY QUICK LAB RSV TEST
K021789	Respiratory Syncytial Virus	Virology	08/29/2003
Cardinal Health Leader TrueTrack Smart System, Blood Glucose Monitoring System
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/22/2003
CVS Pharmacy Blood Glucose System, Truetrack Smart System
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/22/2003
Longs Drugs Truetrack Smart System, Blood Glucose Monitoring System
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/22/2003
SAV-ON OSCO BY ALBERTSON'S TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/22/2003
The Medicine Shoppe Truetrack Smart System, Blood Glucose Monitoring System
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/22/2003
Walgreens Blood Glucose System, Truetrack Smart System
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/22/2003
YOUR 1ST CHOICE FOR VALUE! TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/22/2003
Binax NOW RSV Test
K021687	Respiratory Syncytial Virus	Virology	08/21/2003
Beckman Coulter ICON SC Strep A test
K023766	Streptococcus, Group A	Bacteriology	08/08/2003
HMD BIOMEDICAL GLUCOLEADER VALUE GLUCOSE METER
K023279	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/01/2003
PAN PROBE BIOTECH EARLYDETECT MENOPAUSE TEST FOR FSH
K030058	Follicle Stimulating Hormone (FSH)	Endocrinology	07/31/2003
SACKS BIOLOGICALS AIMSTEP COMBO PREGNANCY
K981165	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/31/2003
SACKS BIOLOGICALS AIMSTEP PREGNANCY
K980531	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/31/2003
UNIPATH CLEARBLUE EASY OVULATION TEST
K981271	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	07/31/2003
INSTANT TECHNOLOGIES IOVULATION MIDSTEAM OVULATION TEST
K012252	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	07/11/2003
INSTANT TECHNOLOGIES IPREGNANCY HCG URINE PREGNANCY TEST
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/11/2003
INSTANT TECHNOLOGIES IPREGNANCY HCG URINE/SERUM PREGRANCY TEST
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/11/2003
INSTANT TECHNOLOGIES IPREGNANCY PREGNANCY TEST STRIP (URINE)
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/11/2003
PERMAXIM REDISCREEN MIDSTREAM URINE OVULATION TEST
K012252	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	07/11/2003
PERMAXIM REDISCREEN MIDSTREAM URINE PREGNANCY TEST
K983090	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/11/2003
PERMAXIM REDISCREEN PREGNANCY TEST STRIP (URINE)
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/11/2003
PERMAXIM REDISCREEN URINE PREGNANCY CASSETTE DEVICE
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/11/2003
HOME DIAGNOSTICS, TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER
K030703	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/10/2003
PERMAXIM REDISCREEN STREP A RAPID TEST
K010582	Streptococcus, Group A	Bacteriology	07/08/2003
SACKS MEDICAL REFUAH STREP A RAPID TEST
K010582	Streptococcus, Group A	Bacteriology	07/08/2003
INSTANT TECHNOLOGIES, ISTREP STREP A
K010582	Streptococcus, Group A	Bacteriology	07/03/2003
ROCHE DIAGNOSTICS ACCU-CHEK COMPACT TEST SYSTEM
K031755	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/03/2003
ACCESS BIO INC. CARESTART HCG COMBO ONE-STEP PREGNANCY TEST
K031048	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/02/2003
ACCESS BIO INC. CARESTART HCG ONE-STEP PREGNANCY TEST
K031052	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/02/2003
ACCESS BIO INC. CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
K031048	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/02/2003
ACCESS BIO INC. CARESTART PLUS HCG ONE-STEP PREGNANCY TEST
K031052	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/02/2003
MAINLINE MAXIE HCG URINE PREGNANCY TEST
K031445	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/02/2003
MEDLINE INDUSTRIES EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K031843	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/02/2003
APPLIED BIOTECH, INC. RU25 PLUS FSH MENOPAUSE TEST
K023408	Follicle Stimulating Hormone (FSH)	Endocrinology	06/24/2003
AMERISOURCE PHARMACAL ONE-STEP PREGNANCY TEST
K031271	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/23/2003
ROCHE DIAGNOSTICS COAGUCHEK {PT-S TEST STRIPS}
K021190	Prothrombin Time (PT)	Hematology	06/18/2003
SACKS MEDICAL CORPORATION REFUAH HCG-COMBO IMMUNOCHEMICAL TEST
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/17/2003
SACKS MEDICAL CORPORATION REFUAH HCG-URINE IMMUNOCHEMICAL TEST
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/17/2003
Acon Strep A Twist Rapid Test
K023766	Streptococcus, Group A	Bacteriology	06/12/2003
HOME DIAGNOSTICS MCKESSON SUNMARK BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/12/2003
TECO DIAGNOSTICS, URS-1P (PROTEIN TEST)
K023172	Urine Qualitative Dipstick Protein	Urinalysis	06/05/2003
ZER HITECH EASYCUP
K023823	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/29/2003
BAYER ASCENSIA CONTOUR DIABETES CARE SYSTEM
K023657	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/28/2003
ABBOTT MEDISENSE PRECISON XTRA/OPTIUM BLOOD GLUCOSE TEST STRIPS WITH TRUE MEASURE TECHNOLOGY
K023256	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/23/2003
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
K031388	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/23/2003
INSTANT TECHNOLOGIES HCG ONE STEP PREGNANCY TEST STRIP (URINE/SERUM)
K980736	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/23/2003
MEDLINE INDUSTRIES EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K011240	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/23/2003
CHEMICON MONOHAEM
K901064	Fecal Occult Blood	General Chemistry	05/15/2003
TECO DIAGNOSTICS URS-1N (NITRITE TEST)
K023325	Urine Qualitative Dipstick Nitrite	Urinalysis	05/15/2003
TECO DIAGNOSTICS, URINE REAGENT STRIPS (URS-1B) TESTS FOR BLOOD
K023297	Urine Qualitative Dipstick Blood	Urinalysis	05/15/2003
HEMOCUE DONOR HEMOGLOBIN CHECKER SYSTEM
BK030020	HGB, SINGLE ANALYTE INST. W/SELF-CONT...	Hematology	05/14/2003
UNIPATH CLEARBLUE EASY DIGITAL PREGNANCY TEST {OTC}
K030659	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/14/2003
BECKMAN COULTER ICON MICROALB
K022538	Albumin, Urinary	General Chemistry	05/13/2003
INSTANT TECHNOLOGIES IPREGNANCY MIDSTREAM PREGNANCY TEST
K983090	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/12/2003
BINAX NOW FLU A TEST
K021649	Influenza A	Virology	05/08/2003
Binax NOW Flu B Test {Nashal Wash, Nasopharyngeal}
K021646	Influenza B	Virology	05/08/2003
ALIDEX, INC. POLY STAT SERUM/URINE HCG TEST
K030430	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/01/2003
BAYER DIAGNOSTICS ASCENCIA BREEZE BLOOD GLUCOSE METER
K024062	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/01/2003
CENOGENICS ACCUNATE HOME PREGNANCY TEST
K030533	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)
K030447	Amphetamines	Toxicology / TDM	05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)
K030447	Cannabinoids (THC)	Toxicology / TDM	05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)
K030447	Cocaine Metabolites	Toxicology / TDM	05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)
K030447	Opiates	Toxicology / TDM	05/01/2003
PHAMATECH AT HOME DRUG TEST (MODEL 9150X)
K030447	Methamphetamine/Amphetamine	Toxicology / TDM	05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB
K896454	Urine Qualitative Dipstick Blood	Urinalysis	05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB
K896454	Urine Qualitative Dipstick Glucose	Urinalysis	05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB
K896454	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB
K896454	Urine Qualitative Dipstick Nitrite	Urinalysis	05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 5 OB
K896454	Urine Qualitative Dipstick Protein	Urinalysis	05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7
K896454	Urine Qualitative Dipstick Ketone	Urinalysis	05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7
K896454	Urine Qualitative Dipstick Blood	Urinalysis	05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7
K896454	Urine Qualitative Dipstick Glucose	Urinalysis	05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7
K896454	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7
K896454	Urine Qualitative Dipstick Nitrite	Urinalysis	05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7
K896454	Urine Qualitative Dipstick Ph	Urinalysis	05/01/2003
ROCHE DIAGNOSTICS CHEMSTRIP 7
K896454	Urine Qualitative Dipstick Protein	Urinalysis	05/01/2003
SA SCIENTIFIC SURE-VUE URINE HCG
K010593	hCG, Urine	Endocrinology	05/01/2003
WAMPOLE PREVUE HCG CASSETTE URINE OR SERUM
K992187	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/01/2003
ADC CLIA WAIVED MARIJUANA (THC) AND COCAINE TEST
K003708	Cannabinoids (THC)	Toxicology / TDM	04/30/2003
ADC CLIA WAIVED MARIJUANA (THC) AND COCAINE TEST
K003708	Cocaine Metabolites	Toxicology / TDM	04/30/2003
ADC CLIA WAIVED MARIJUANA (THC) TEST
K001567	Cannabinoids (THC)	Toxicology / TDM	04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD
K001126	Cannabinoids (THC)	Toxicology / TDM	04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD
K001126	Phencyclidine (PCP)	Toxicology / TDM	04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD
K001126	Cocaine Metabolites	Toxicology / TDM	04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD
K001126	Opiates	Toxicology / TDM	04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD
K001126	Methamphetamines	Toxicology / TDM	04/29/2003
ADVANCED DIAGNOSTICS INC MIDSTREAM PREGNANCY TEST
K023037	hCG, Urine	Endocrinology	04/15/2003
GERMAINE LABORATORIES ACCUHOME OVULATION
X030008	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	03/27/2003
GI SUPPLY, DIV. CHEK-MED SYSTEMS HP ONE
K012411	Helicobacter Pylori	Bacteriology	03/24/2003
ALATEX SCIENTIFIC PEACE OF MIND MARIJUANA (THC) AND COCAINE HOME DRUG TEST
K011962	Cannabinoids (THC)	Toxicology / TDM	03/17/2003
ALATEX SCIENTIFIC PEACE OF MIND MARIJUANA (THC) AND COCAINE HOME DRUG TEST
K011962	Cocaine Metabolites	Toxicology / TDM	03/17/2003
HOME DIAGNOSTICS DUANE READE BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/13/2003
GENZYME OSOM MONO TEST
K972231	Infectious Mononucleosis Antibodies (Mono)	General Immunology	03/06/2003
TECO DIAGNOSTICS, URINE REAGENT STRIPS (URS-1B) TESTS FOR BLOOD
K023297	Urine Qualitative Dipstick Blood	Urinalysis	03/06/2003
INVERNESS MEDICAL ACCUCLEAR EARLY PREGNANCY TEST
K002049	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/05/2003
STANBIO QUSTICK STREP A
K010582	Streptococcus, Group A	Bacteriology	03/05/2003
STANBIO TRUE 20 ONE-STEP PREGNANCY TEST
K980531	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/05/2003
TECO DIAGNOSTICS URS-1N (NITRITE TEST)
K023325	Urine Qualitative Dipstick Nitrite	Urinalysis	02/28/2003
TECO DIAGNOSTICS, URS-1P (PROTEIN TEST)
K023172	Urine Qualitative Dipstick Protein	Urinalysis	02/28/2003
IND DIAGNOSTIC ONE STEP CASSETTE STYLE HCG URINE PREGNANCY TEST
K023638	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/21/2003
GENZYME CONTRAST II HCG URINE/SERUM
K023544	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/13/2003
IMMUNOSTICS IMMUNO/STREP A DETECTOR
K010582	Streptococcus, Group A	Bacteriology	02/13/2003
BAYER DIAGNOSTICS CLINITEST HCG PREGNANCY TEST
K023944	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/12/2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
K023561	HGB, SINGLE ANALYTE INST. W/SELF-CONT...	Hematology	02/12/2003
AERSCHER HEMAPROMPT FG
K972763	Gastric Occult Blood	General Chemistry	02/11/2003
ABBOTT MEDISENSE {PRECISION XTRA COMPLETE}
K983504	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/10/2003
ABBOTT MEDISENSE {OPTIUM COMPLETE}
K983504	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/10/2003
LIFESCAN ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K024194	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/10/2003
LIFESCAN ONETOUCH IN DUO BLOOD GLUCOSE MONITORING SYSTEM
K024194	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/10/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA
K022386	Urine Qualitative Dipstick Ketone	Urinalysis	02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA
K022386	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA
K022386	Urine Qualitative Dipstick Blood	Urinalysis	02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA
K022386	Urine Qualitative Dipstick Glucose	Urinalysis	02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA
K022386	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA
K022386	Urine Qualitative Dipstick Nitrite	Urinalysis	02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA
K022386	Urine Qualitative Dipstick Ph	Urinalysis	02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA
K022386	Urine Qualitative Dipstick Protein	Urinalysis	02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA
K022386	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA
K022386	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/06/2003
HERITAGE HOUSE '76, INC. PRECIOUS FEET PREGNANCY TEST
K023638	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/06/2003
APPLIED BIOTECH DRUGFREE @HOME COCAINE TEST
K022805	Cocaine Metabolites	Toxicology / TDM	02/04/2003
APPLIED BIOTECH DRUGFREE @HOME THC TEST  (OTC)
K022802	Cannabinoids (THC)	Toxicology / TDM	02/04/2003
APPLIED BIOTECH INSTACHECK OVULATION TEST  (OTC)
K023295	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	02/04/2003
APPLIED BIOTECH MENOPAUSE PREDICTOR TEST
K023408	Follicle Stimulating Hormone (FSH)	Endocrinology	02/04/2003
ORASURE ORAQUICK RAPID HIV-1 TEST
BP010047	HIV-1 Antibody	General Immunology	01/31/2003
JANT PHARMACAL CLINIPAK
K993317	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/24/2003
FOREFRONT DIAGNOSTICS INSTACHECK DRUG SCREEN THC
K971959	Cannabinoids (THC)	Toxicology / TDM	01/23/2003
FOREFRONT DIAGNOSTICS INSTACHECK MULTI-DRUG SCREEN PANEL  (THC/COC)
K993863	Cannabinoids (THC)	Toxicology / TDM	01/23/2003
FOREFRONT DIAGNOSTICS INSTACHECK MULTI-DRUG SCREEN PANEL  (THC/COC)
K993863	Cocaine Metabolites	Toxicology / TDM	01/23/2003
ABBOTT MEDISENSE PRECISION /OPTIMUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS WITH TRUE MEASURE TECHNOLOGY
K021960	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/13/2003
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS HEMOCCULT II SENSA ELITE
K880499	Fecal Occult Blood	General Chemistry	01/13/2003
BIO-RAD MICROMAT II HEMOGLOBIN A1C PRESCRIPTION HOME USE TEST
K021935	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	12/17/2002
LIFESCAN SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K023832	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2002
SA SCIENTIFIC SAS BLOOD/SERUM/URINE HCG
K022683	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/17/2002
YD DIAGNOSTICS PREG-Q PREGNANCY TEST
K023027	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/17/2002
ADVANTAGE DIAGNOSTICS ADVANTAGE THC TEST
K001567	Cannabinoids (THC)	Toxicology / TDM	12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST
K001126	Cannabinoids (THC)	Toxicology / TDM	12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST
K001126	Phencyclidine (PCP)	Toxicology / TDM	12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST
K001126	Cocaine Metabolites	Toxicology / TDM	12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST
K001126	Opiates	Toxicology / TDM	12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST
K001126	Methamphetamines	Toxicology / TDM	12/09/2002
PHAMATECH AT HOME QUICK CUP PREGNANCY TEST
K993141	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/09/2002
PHAMATECH CLEAR CHOICE PREGNANCY TEST
K993141	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/09/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer
K010973	Urine Qualitative Dipstick Ketone	Urinalysis	12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer
K010973	Urine Qualitative Dipstick Bilirubin	Urinalysis	12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer
K010973	Urine Qualitative Dipstick Blood	Urinalysis	12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer
K010973	Urine Qualitative Dipstick Glucose	Urinalysis	12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer
K010973	Urine Qualitative Dipstick Leukocytes	Urinalysis	12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer
K010973	Urine Qualitative Dipstick Nitrite	Urinalysis	12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer
K010973	Urine Qualitative Dipstick Ph	Urinalysis	12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer
K010973	Urine Qualitative Dipstick Protein	Urinalysis	12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer
K010973	Urine Qualitative Dipstick Urobilinogen	Urinalysis	12/06/2002
Hypoguard, DiaScreen 50 Urine Chemistry Analyzer
K010973	Urine Qualitative Dipstick Specific Gravity	Urinalysis	12/06/2002
ADVANTAGE DIAGNOSTICS ADVANTAGE THC/COCAINE TEST
K003708	Cannabinoids (THC)	Toxicology / TDM	12/03/2002
ADVANTAGE DIAGNOSTICS ADVANTAGE THC/COCAINE TEST
K003708	Cocaine Metabolites	Toxicology / TDM	12/03/2002
HEMOSENSE INRATIO SYSTEM
K020679	Prothrombin Time (PT)	Hematology	12/03/2002
UNIPATH CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/27/2002
AMEDITECH IMMUTEST HCG PREGNANCY TEST
K023126	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/21/2002
LIFESCAN HARMONY INR MONITORING SYSTEM  (Professional Use)
K022922	Prothrombin Time (PT)	Hematology	11/21/2002
LIFESCAN HARMONY INR MONITORY SYSTEM  (Prescription Home Use)
K022922	Prothrombin Time (PT)	Hematology	11/21/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS}
K023558	Triglyceride	General Chemistry	11/21/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS}
K023558	HDL Cholesterol	General Chemistry	11/21/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS}
K023558	Cholesterol	General Chemistry	11/21/2002
Polymer Technology Systems CardioChek Analyzer {PTS PANELS LIPID PANEL TEST STRIPS}
K023558	Triglyceride	General Chemistry	11/21/2002
Polymer Technology Systems CardioChek Analyzer {PTS PANELS LIPID PANEL TEST STRIPS}
K023558	HDL Cholesterol	General Chemistry	11/21/2002
Polymer Technology Systems CardioChek Analyzer {PTS PANELS LIPID PANEL TEST STRIPS}
K023558	Cholesterol	General Chemistry	11/21/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS}
K023558	Triglyceride	General Chemistry	11/21/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS}
K023558	HDL Cholesterol	General Chemistry	11/21/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS}
K023558	Cholesterol	General Chemistry	11/21/2002
PHAMATECH OVUCARD LH TEST  (Cassette)
K990249	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	11/20/2002
PHAMATECH OVUSTICK LH TEST  (strip)
K990249	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	11/20/2002
DE HEALTHCARE PRODUCTS TRU VIEW ONE-STEP PREGNANCY TEST
K990578	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/19/2002
Metrika A1cNow For Home Use
K022661	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	11/19/2002
SOLARTEK PRODUCTS, RITE AID BLOOD GLUCOSE MONITORING SYSTEM
K983504	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/15/2002
Roche Diagnostics CoaguChek S System {PT-S TEST STRIPS}
K020831	Prothrombin Time (PT)	Hematology	11/14/2002
IMMUNOCARD STAT! HCG COMBO ADVANTAGE PREGNANCY TEST
K992187	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/13/2002
IND DIAGNOSTIC ONE STEP CASSETTE STYLE HCG SERUM/URINE COMBO TEST
K974009	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/13/2002
ROCHE DIAGNOSTICS COAGUCHEK {PT-S TEST STRIPS}
K021190	Prothrombin Time (PT)	Hematology	11/12/2002
HOME DIAGNOSTICS MEDLINE BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/08/2002
HOME DIAGNOSTICS SHOPRITE BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/08/2002
ABBOTT MEDISENSE PCX BLOOD GLUCOSE TESTING SYSTEM
K022941	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/01/2002
ABBOTT MEDISENSE PCX PLUS BLOOD GLUCOSE TEST STRIPS
K022941	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/01/2002
ALFA SCIENTIFIC DESIGNS INSTANT-VIEW LH OVULATION PREDICTING TEST  (Cassette)
K022829	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	11/01/2002
AZOG INC HCG URINE ONE STEP URINE PREGNANCY TEST  (Dipstick)
K022680	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/01/2002
AZOG INC HCG URINE ONE STEP URINE PREGNANCY TEST  (Cassette)
K022681	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/01/2002
LIFESCAN SURESTEP FLEXX BLOOD GLUCOSE MONITORING SYSTEM
K023194	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/01/2002
LIFESCAN SURESTEP PRO
K023194	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/01/2002
DE HEALTHCARE PRODUCTS TRUVIEW STREP A TEST
K992658	Streptococcus, Group A	Bacteriology	10/23/2002
HENRY SCHEIN ONE STEP+ STREP A TEST
K992658	Streptococcus, Group A	Bacteriology	10/23/2002
GERMAINE LABORATORIES STREPAIM RAPID DIPSTICK TEST
K010582	Streptococcus, Group A	Bacteriology	10/21/2002
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM
K982076	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/18/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS}
K022898	Triglyceride	General Chemistry	10/18/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS}
K022898	HDL Cholesterol	General Chemistry	10/18/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS {PTS PANELS LIPID PANEL TEST STRIPS}
K022898	Cholesterol	General Chemistry	10/18/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS}
K022898	Triglyceride	General Chemistry	10/18/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS}
K022898	HDL Cholesterol	General Chemistry	10/18/2002
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS LIPID PANEL TEST STRIPS}
K022898	Cholesterol	General Chemistry	10/18/2002
SCITECK DIAGNOSTICS BABYCHECK ONE STEP PREGNANCY TEST
K960174	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/18/2002
BECTON DICKINSON LATITUDE DIABETES MANAGEMENT SYSTEM
K022580	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/08/2002
BECTON DICKINSON LOGIC GLUCOSE MONITOR
K022581	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/08/2002
HYPOGUARD GLUCOBALANCE DATA MANAGEMENT SOFTWARE
K022545	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	10/08/2002
INTERNATIONAL NEWTECH DEVELOP. MINISTRIP HCG ONESTEP
K974059	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/25/2002
PHAMATECH ONE-STEP OPIATE DRUG SCREENING TEST {Cassette}
K972619	Opiates	Toxicology / TDM	09/20/2002
PHAMATECH QUICKSCREEN ONE-STEP OPIATE {DIP}
K972619	Opiates	Toxicology / TDM	09/20/2002
ABBOTT MEDISENSE RELION DIABETES CARE STARTER KIT
K944195	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/18/2002
HERITAGE HOUSE '76, INC. PRECIOUS FEET PREGNANCY TEST
K980531	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/09/2002
LIFESCAN ONETOUCH SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K022724	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/09/2002
MEDISENSE OPTIUM EASY BLOOD GLUCOSE TESTING SYSTEM
K022182	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/06/2002
MEDISENSE PRECISION EASY BLOOD GLUCOSE TESTING SYSTEM
K022182	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/06/2002
BIOTEST HEMOGLOBIN MEASURING SYSTEM
K020710	HGB, SINGLE ANALYTE INST. W/SELF-CONT...	Hematology	08/29/2002
DIAGNOSTIC CHEMICALS IMMUNODIP URINARY ALBUMIN TEST
K022538	Albumin, Urinary	General Chemistry	08/29/2002
HOME DIAGNOSTICS PRESTIGE IQ BLOOD GLUCOSE SYSTEM {CHAY MEDICAL 3 MICROLITER EXCELSIOR TEST STRIPS}
K021781	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/29/2002
HOME DIAGNOSTICS PRESTIGE LX BLOOD GLUCOSE SYSTEM {CHAY MEDICAL 3 MICROLITER EXCELSIOR TEST STRIPS}
K021781	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/29/2002
LIFESCAN ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K021819	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)
K993165	Amphetamines	Toxicology / TDM	08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)
K993165	Cannabinoids (THC)	Toxicology / TDM	08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)
K993165	Phencyclidine (PCP)	Toxicology / TDM	08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)
K993165	Cocaine Metabolites	Toxicology / TDM	08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)
K993165	Opiates	Toxicology / TDM	08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9177)
K993165	Methamphetamines	Toxicology / TDM	08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)
K993165	Amphetamines	Toxicology / TDM	08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)
K993165	Cannabinoids (THC)	Toxicology / TDM	08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)
K993165	Phencyclidine (PCP)	Toxicology / TDM	08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)
K993165	Cocaine Metabolites	Toxicology / TDM	08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)
K993165	Opiates	Toxicology / TDM	08/29/2002
PHAMATECH QUICKSCREEN PRO MULTI DRUG SCREENING TEST (MODEL 9178)
K993165	Methamphetamines	Toxicology / TDM	08/29/2002
LUNA FERTILITY INDICATOR
K020953	Fern Test, Saliva	Endocrinology	08/26/2002
O2 UNLIMITED DONNA OVULATION TESTER
K020811	Fern Test, Saliva	Endocrinology	08/26/2002
PHAMATECH QUICKSCREEN PCP DRUG SCREENING TEST  (DIP)
K974582	Phencyclidine (PCP)	Toxicology / TDM	08/26/2002
PHAMATECH QUICKSCREEN PCP DRUG SCREENING TEST  (Cassette)
K974582	Phencyclidine (PCP)	Toxicology / TDM	08/26/2002
STESANS MAYBE?MOM MINI OVULATION MICROSCOPE
K013582	Fern Test, Saliva	Endocrinology	08/26/2002
PHAMATECH QUICK SCREEN THC DRUG SCREENING TEST  (Cassette)
K973122	Cannabinoids (THC)	Toxicology / TDM	08/23/2002
PHAMATECH QUICK SCREEN THC DRUG SCREENING TEST  (DIP)
K973122	Cannabinoids (THC)	Toxicology / TDM	08/23/2002
PHAMATECH QUICKSCREEN AMPHETAMINE DRUG SCREENING TEST  (Cassette)
K972577	Amphetamines	Toxicology / TDM	08/23/2002
PHAMATECH QUICKSCREEN AMPHETAMINE DRUG SCREENING TEST  (DIP)
K972577	Amphetamines	Toxicology / TDM	08/23/2002
PHAMATECH QUICKSCREEN COCAINE DRUG SCREENING TEST  (Cassette)
K972618	Cocaine Metabolites	Toxicology / TDM	08/23/2002
PHAMATECH QUICKSCREEN COCAINE DRUG SCREENING TEST  (DIP)
K972618	Cocaine Metabolites	Toxicology / TDM	08/23/2002
PHAMATECH QUICKSCREEN METHAMPHETAMINE DRUG SCREEN TEST  (Cassette)
K972556	Methamphetamines	Toxicology / TDM	08/23/2002
PHAMATECH QUICKSCREEN METHAMPHETAMINE DRUG SCREEN TEST  (DIP)
K972556	Methamphetamines	Toxicology / TDM	08/23/2002
ALIDEX, INC. POLY STAT HCG DIPSTICK TEST
K021386	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/20/2002
MATRITECH BLADDERCHEK  (Prescription Home Use)
K021231	Bladder Tumor Associated Antigen	General Immunology	08/12/2002
MATRITECH BLADDERCHEK  (Professional Use)
K021231	Bladder Tumor Associated Antigen	General Immunology	08/12/2002
MERIDIAN BIOSCIENCE IMMUNOCARD STAT! H. PYLORI WHOLE BLOOD TEST
K990892	Helicobacter Pylori Antibodies	General Immunology	08/09/2002
SERIM PYLORITEK VP TEST KIT
K014038	Helicobacter Pylori	Bacteriology	07/25/2002
ROCHE DIAGNOSTICS ACCU-CHEK COMPACT TEST SYSTEM
K022171	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/22/2002
GENZYME OSOM ULTRA STREP A TEST  (25 TEST KIT)
K992658	Streptococcus, Group A	Bacteriology	07/19/2002
PAN PROBE BIOTECH LIVESURE HCG URINARY PREGNANCY TEST CARD
K020968	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/15/2002
PAN PROBE BIOTECH LIVESURE HCG URINARY PREGNANCY TEST STRIP
K020968	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/15/2002
HEMOCUE GLUCOSE 201 MICROCUVETTES AND GLUCOSE 201 ANALYZER WITH PLASMA CONVERSION
K020935	Glucose	General Chemistry	07/12/2002
Quidel QuickVue In-Line Strep A
K934484	Streptococcus, Group A	Bacteriology	07/08/2002
ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM
K021827	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/02/2002
CHOLESTECH GDX A1C TEST  (Prescription Home Use)
K011933	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	07/01/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS
K981493	Cholesterol	General Chemistry	06/25/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS
K990247	HDL Cholesterol	General Chemistry	06/25/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS
K990688	Cholesterol	General Chemistry	06/25/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS
K993377	HDL Cholesterol	General Chemistry	06/25/2002
Polymer Technology Systems CardioChek Analyzer
K014099	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/25/2002
Polymer Technology Systems CardioChek PA Analyzer
K014099	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/25/2002
POLYMER TECHNOLOGY SYSTEMS PTS GLUCOSE Q3
K014099	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/25/2002
POLYMER TECHNOLOGY SYSTEMS PTS PANELS GLUCOSE TEST STRIPS
K014099	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/25/2002
STANBIO QUPID PLUS E.R. ONE STEP PREGNANCY
K020378	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/19/2002
Bayer Diagnostics Ascensia DEX 2 Diabetes Care System
K963500	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/14/2002
BAYER DIAGNOSTICS GLUCODISC BLOOD GLUCOSE TEST STRIPS
K012205	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/14/2002
QUIDEL OVUQUICK ONE-STEP OVULATION PREDICTOR
K953063	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	06/13/2002
QUIDEL QUICKVUE ADVANCE PH AND AMINES TEST
K962718	Vaginal pH	General Chemistry	06/13/2002
QUIDEL QUICKVUE ADVANCE PH AND AMINES TEST
K962718	Amines	General Chemistry	06/13/2002
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST
K020869	Amphetamines	Toxicology / TDM	06/13/2002
DE HEALTHCARE PRODUCTS HCG STRIP TEST
K941090	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/12/2002
HENRY SCHEIN ONESTEP + HCG STRIP TEST
K941090	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/12/2002
HENRY SCHEIN ONESTEP + HCG TEST
K941090	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/12/2002
IMMUNOSTICS IMMUNO DETECTOR COMBI
K013194	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/12/2002
IMMUNOSTICS IMMUNO DETECTOR PERSONAL
K960174	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/12/2002
WAMPOLE PREVUE HCG STICK URINE OR SERUM
K925303	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/12/2002
PRINCETON BIOMEDITECH ACCUSIGN COC
K014069	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN DOA 4 (THC/OPI/COC/MET)
K014193	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN DOA 4 (THC/OPI/COC/MET)
K014193	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN DOA 4 (THC/OPI/COC/MET)
K014193	Opiates	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN DOA 4 (THC/OPI/COC/MET)
K014193	Methamphetamines	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK COC
K014069	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK MET
K014192	Methamphetamines	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC
K014066	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/OPI/COC/MET
K014193	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/OPI/COC/MET
K014193	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/OPI/COC/MET
K014193	Opiates	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/OPI/COC/MET
K014193	Methamphetamines	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN THC
K014066	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK COC
K014069	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK DOA4
K014193	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK DOA4
K014193	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK DOA4
K014193	Opiates	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK DOA4
K014193	Methamphetamines	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK MET
K014192	Methamphetamines	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTIK THC
K014066	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP COC
K014069	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP DOA4 (THC/OPI/COC/MET)
K014193	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP DOA4 (THC/OPI/COC/MET)
K014193	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP DOA4 (THC/OPI/COC/MET)
K014193	Opiates	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP DOA4 (THC/OPI/COC/MET)
K014193	Methamphetamines	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP MET
K014192	Methamphetamines	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH ACCUSTRIP THC
K014066	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
Princeton BioMeditech LifeSign Home Drug Test (MET)
K014192	Methamphetamines	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/OPI/COC/MET)
K014193	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/OPI/COC/MET)
K014193	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/OPI/COC/MET)
K014193	Opiates	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/OPI/COC/MET)
K014193	Methamphetamines	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST COCAINE
K014069	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST MARIJUANA
K014066	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS DS COC
K014069	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS DS DOA4 (THC/OPI/COC/MET)
K014193	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS DS DOA4 (THC/OPI/COC/MET)
K014193	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS DS DOA4 (THC/OPI/COC/MET)
K014193	Opiates	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS DS DOA4 (THC/OPI/COC/MET)
K014193	Methamphetamines	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS DS MET
K014192	Methamphetamines	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS DS THC
K014066	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS STIK COC
K014069	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS STIK MET
K014192	Methamphetamines	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC
K014066	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC/OPI/COC/MET
K014193	Cannabinoids (THC)	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC/OPI/COC/MET
K014193	Cocaine Metabolites	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC/OPI/COC/MET
K014193	Opiates	Toxicology / TDM	06/07/2002
PRINCETON BIOMEDITECH STATUS STIK THC/OPI/COC/MET
K014193	Methamphetamines	Toxicology / TDM	06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS
K983510	Urine Qualitative Dipstick Ketone	Urinalysis	06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS
K983510	Urine Qualitative Dipstick Bilirubin	Urinalysis	06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS
K983510	Urine Qualitative Dipstick Blood	Urinalysis	06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS
K983510	Urine Qualitative Dipstick Glucose	Urinalysis	06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS
K983510	Urine Qualitative Dipstick Leukocytes	Urinalysis	06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS
K983510	Urine Qualitative Dipstick Nitrite	Urinalysis	06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS
K983510	Urine Qualitative Dipstick Ph	Urinalysis	06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS
K983510	Urine Qualitative Dipstick Protein	Urinalysis	06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS
K983510	Urine Qualitative Dipstick Urobilinogen	Urinalysis	06/07/2002
ROCHE DIAGNOSTICS CHEMSTRIP 10 MD TEST STRIPS
K983510	Urine Qualitative Dipstick Specific Gravity	Urinalysis	06/07/2002
WAMPOLE PREVUE HCG CASSETTE URINE OR SERUM
K925125	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/07/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/COC
K014067	Cannabinoids (THC)	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH ACCUSIGN STIK THC/COC
K014067	Cocaine Metabolites	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH ACCUSIGN THC/COC
K014067	Cannabinoids (THC)	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH ACCUSIGN THC/COC
K014067	Cocaine Metabolites	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH ACCUSTIK THC/COC
K014067	Cannabinoids (THC)	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH ACCUSTIK THC/COC
K014067	Cocaine Metabolites	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH ACCUSTRIP THC/COC
K014067	Cannabinoids (THC)	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH ACCUSTRIP THC/COC
K014067	Cocaine Metabolites	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/COC)
K014067	Cannabinoids (THC)	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH LIFESIGN HOME DRUG TEST (THC/COC)
K014067	Cocaine Metabolites	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH STATUS DS THC/COC
K014067	Cannabinoids (THC)	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH STATUS DS THC/COC
K014067	Cocaine Metabolites	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH STATUS STIK THC/COC
K014067	Cannabinoids (THC)	Toxicology / TDM	06/06/2002
PRINCETON BIOMEDITECH STATUS STIK THC/COC
K014067	Cocaine Metabolites	Toxicology / TDM	06/06/2002
ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM
K021448	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/06/2002
PRINCETON BIOMEDITECH BIOSIGN HCG SERUM/URINE
K020439	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/23/2002
PRINCETON BIOMEDITECH STATUS HCG SERUM/URINE
K020439	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/23/2002
HYPOGUARD ASSURE BLOOD GLUCOSE SYSTEM
K980573	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/21/2002
Hypoguard Assure II Blood Glucose Monitoring System
K002621	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/21/2002
HYPOGUARD DIASCREEN 10
K981555	Urine Qualitative Dipstick Ketone	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 10
K981555	Urine Qualitative Dipstick Bilirubin	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 10
K981555	Urine Qualitative Dipstick Blood	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 10
K981555	Urine Qualitative Dipstick Glucose	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 10
K981555	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 10
K981555	Urine Qualitative Dipstick Nitrite	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 10
K981555	Urine Qualitative Dipstick Ph	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 10
K981555	Urine Qualitative Dipstick Protein	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 10
K981555	Urine Qualitative Dipstick Urobilinogen	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 10
K981555	Urine Qualitative Dipstick Specific Gravity	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 1B
K981555	Urine Qualitative Dipstick Blood	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 40BL
K981555	Urine Qualitative Dipstick Blood	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 40BL
K981555	Urine Qualitative Dipstick Glucose	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 40BL
K981555	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 40BL
K981555	Urine Qualitative Dipstick Protein	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 4NL
K981555	Urine Qualitative Dipstick Glucose	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 4NL
K981555	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 4NL
K981555	Urine Qualitative Dipstick Nitrite	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 4PH
K981555	Urine Qualitative Dipstick Blood	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 4PH
K981555	Urine Qualitative Dipstick Glucose	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 4PH
K981555	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 4PH
K981555	Urine Qualitative Dipstick Nitrite	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 4PH
K981555	Urine Qualitative Dipstick Ph	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 4PH
K981555	Urine Qualitative Dipstick Protein	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 9
K981555	Urine Qualitative Dipstick Blood	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 9
K981555	Urine Qualitative Dipstick Glucose	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 9
K981555	Urine Qualitative Dipstick Nitrite	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 9
K981555	Urine Qualitative Dipstick Ph	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 9
K981555	Urine Qualitative Dipstick Protein	Urinalysis	05/17/2002
HYPOGUARD DIASCREEN 9
K981555	Urine Qualitative Dipstick Urobilinogen	Urinalysis	05/17/2002
PSS SELECT REAGENT STRIPS FOR URINALYSIS
K981555	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	05/17/2002
QUIDEL QUICKVUE ONE-STEP HCG-COMBO
K020801	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/17/2002
QUIDEL QUICKVUE ONE-STEP HCG-URINE
K020799	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS
K896454	Urine Qualitative Dipstick Ketone	Urinalysis	05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS
K896454	Urine Qualitative Dipstick Bilirubin	Urinalysis	05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS
K896454	Urine Qualitative Dipstick Blood	Urinalysis	05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS
K896454	Urine Qualitative Dipstick Glucose	Urinalysis	05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS
K896454	Urine Qualitative Dipstick Leukocytes	Urinalysis	05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS
K896454	Urine Qualitative Dipstick Nitrite	Urinalysis	05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS
K896454	Urine Qualitative Dipstick Ph	Urinalysis	05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS
K896454	Urine Qualitative Dipstick Protein	Urinalysis	05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS
K896454	Urine Qualitative Dipstick Urobilinogen	Urinalysis	05/17/2002
ROCHE DIAGNOSTICS CHOICELINE URINE 10 TEST STRIPS
K896454	Urine Qualitative Dipstick Specific Gravity	Urinalysis	05/17/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS GLUCOSE TEST STRIPS
K972669	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/10/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS GLUCOSE TEST STRIPS
K013068	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/10/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS KETONE TEST STRIPS
K981865	Ketone, Blood	General Chemistry	05/10/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS KETONE TEST STRIPS
K983860	Ketone, Blood	General Chemistry	05/10/2002
BAYER DIAGNOSTICS ASCENCIA ELITE BLOOD GLUCOSE METER
K990649	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/06/2002
BAYER DIAGNOSTICS ASCENCIA ELITE XL BLOOD GLUCOSE METER
K990649	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/06/2002
BAYER DIAGNOSTICS ASCENSIA ELITE BLOOD GLUCOSE TEST STRIPS
K991242	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/06/2002
BAYER DIAGNOSTICS ASCENSIA ELITE DIABETES CARE SYSTEM
K951537	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/06/2002
BAYER GLUCOMETER DEX 2
K020210	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/01/2002
BAYER GLUCOMETER DEX DIABETES CARE SYSTEM
K020210	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/01/2002
BAYER GLUCOMETER DEX TEST SENSOR
K020210	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/01/2002
BAYER GLUCOMETER ELITE DIABETES CARE SYSTEM
K020208	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/01/2002
BAYER GLUCOMETER ELITE TEST STRIPS
K020208	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/01/2002
BAYER GLUCOMETER ELITE XL DIABETES CARE SYSTEM
K020208	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	05/01/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER 2000 PTS PANELS TRIGLYCERIDES TEST STRIPS  (For OTC use)
K000586	Triglyceride	General Chemistry	04/30/2002
DE HEALTHCARE PRODUCTS DETECT~OCCULT SLIDE TEST FOR FECAL OCCULT BLOOD
K902360	Fecal Occult Blood	General Chemistry	04/05/2002
HENRY SCHEIN ONE STEP SLIDE TEST FOR FECAL OCCULT BLOOD
K902360	Fecal Occult Blood	General Chemistry	04/05/2002
TECO DIAGNOSTICS URINE REAGENT STRIPS (URS-1G)
K020175	Urine Qualitative Dipstick Glucose	Urinalysis	03/21/2002
THERMO BIOSTAR ACCEAVA HCG COMBO URINE/SERUM TEST
K964155	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/21/2002
POLYMEDICA PHARMACEUTICALS, U.S.A. LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
K014167	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/14/2002
UNIPATH CLEARPLAN EASY OVULATION TEST
K013874	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	03/14/2002
HOME DIAGNOSTICS BROOKS BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/12/2002
HOME DIAGNOSTICS ECKERD BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/12/2002
HOME DIAGNOSTICS KERR DRUG BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/12/2002
HOME DIAGNOSTICS PREFERRED PLUS PHARMACY BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/12/2002
HOME DIAGNOSTICS VALU-RITE BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/12/2002
METRIKA A1CNOW FOR PRESCRIPTION HOME USE
K020234	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	03/08/2002
Metrika DRX Professional Use Hemoglobin A1c Test
K020235	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	03/08/2002
SA SCIENTIFIC SAS VALUE HCG
K020438	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/08/2002
GERMAINE LABORATORIES AIMSTEP PREGNANCY
K013857	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/03/2002
ROSS PRODUCTS DIVISION FACT PLUS PRO PREGNANCY TEST
K921170	Urine hCG By Visual Color Comparison Tests	Endocrinology	03/02/2002
BAYER NEW MULTIPLES REAGENT STRIPS
K992257	Urine Qualitative Dipstick Ketone	Urinalysis	02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS
K992257	Urine Qualitative Dipstick Bilirubin	Urinalysis	02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS
K992257	Urine Qualitative Dipstick Blood	Urinalysis	02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS
K992257	Urine Qualitative Dipstick Glucose	Urinalysis	02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS
K992257	Urine Qualitative Dipstick Leukocytes	Urinalysis	02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS
K992257	Urine Qualitative Dipstick Nitrite	Urinalysis	02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS
K992257	Urine Qualitative Dipstick Ph	Urinalysis	02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS
K992257	Urine Qualitative Dipstick Protein	Urinalysis	02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS
K992257	Urine Qualitative Dipstick Urobilinogen	Urinalysis	02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS
K992257	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS
K992257	Urine Qualitative Dipstick Creatinine	Urinalysis	02/26/2002
THERASENSE FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
K012014	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/25/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
K013778	Cannabinoids (THC)	Toxicology / TDM	02/21/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
K013778	Phencyclidine (PCP)	Toxicology / TDM	02/21/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
K013778	Cocaine Metabolites	Toxicology / TDM	02/21/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
K013778	Methamphetamines	Toxicology / TDM	02/21/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST
K013778	Morphine	Toxicology / TDM	02/21/2002
GDS TECHNOLOGY STAT-SITE M HGB TEST SYSTEM
K020138	HGB, SINGLE ANALYTE INST. W/SELF-CONT...	Hematology	02/11/2002
HOME DIAGNOSTICS PRESTIGE IQ BLOOD GLUCOSE SYSTEM {CHAY MEDICAL EXCELSIOR TEST STRIPS}
K013342	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/07/2002
HOME DIAGNOSTICS PRESTIGE LX BLOOD GLUCOSE SYSTEM {CHAY MEDICAL EXCELSIOR TEST STRIPS}
K013342	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/07/2002
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
K020232	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/07/2002
Kroger Blood Glucose Monitoring System
K983504	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/10/2002
AMERITEK DBEST URINARY TRACT INFECTION TEST KIT
K990873	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	01/03/2002
CONSUMER CHOICE SYSTEMS URINARY TRACT INFECTION TEST STRIP
K990873	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	01/03/2002
VICTORCH HCG STRIP
K013702	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/03/2002
VICTORCH HCG TEST CARD
K013678	Urine hCG By Visual Color Comparison Tests	Endocrinology	01/03/2002
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER PLUS PROFESSIONAL AND OTC
K014099	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/21/2001
ACON STREP A RAPID TEST STRIP
K010582	Streptococcus, Group A	Bacteriology	12/18/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS ICON DS STREP A
K010582	Streptococcus, Group A	Bacteriology	12/18/2001
CAMBRIDGE DIAGNOSTICS INVERNESS MEDICAL EARLY PREGNANCY TEST
K013907	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/18/2001
APEX BIOTECHNOLOGY CORP. GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
K011233	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2001
HOME DIAGNOSTICS LIFE MEDICAL BLOOD GLUCOSE SYSTEM
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2001
HOME DIAGNOSTICS LONGS BLOOD GLUCOSE SYSTEM
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2001
HOME DIAGNOSTICS MEIJER BLOOD GLUCOSE SYSTEM
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2001
HYPOGUARD ASSURE BLOOD GLUCOSE SYSTEM
K002621	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2001
Hypoguard Assure II Blood Glucose Monitoring System
K011233	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2001
LIFESCAN FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K011479	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2001
LIFESCAN ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K011479	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2001
MEDISENSE SOF-TACT DIABETES MANAGEMENT SYSTEM
K012975	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9064)
K013410	Amphetamines	Toxicology / TDM	12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9069)
K013412	Methamphetamines	Toxicology / TDM	12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9074)
K013409	Cocaine Metabolites	Toxicology / TDM	12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9079)
K013408	Cannabinoids (THC)	Toxicology / TDM	12/17/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9084)
K013407	Opiates	Toxicology / TDM	12/17/2001
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER
K013068	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2001
QUIDEL QUICKVUE URINCHEK 10+SG
K861255	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	12/17/2001
QUIDEL QUICKVUE URINCHEK 10+SG
K861255	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	12/17/2001
QUIDEL QUICKVUE+ INFECTIOUS MONONUCLEOSIS  (Whole Blood)
K902510	Infectious Mononucleosis Antibodies (Mono)	General Immunology	12/17/2001
REMEL RIM A.R.C. HCG COMBO PREGNANCY TEST
K932635	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/17/2001
ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM
K012324	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/17/2001
TCI OVULATION TESTER
K013323	Fern Test, Saliva	Endocrinology	12/05/2001
JANT PHARMACAL ACCUSTRIP HCG PREGNANCY TEST
K954444	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/04/2001
QUIDEL QUICKVUE URINCHEK 2+
K861255	Urine Qualitative Dipstick Glucose	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 2+
K861255	Urine Qualitative Dipstick Protein	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 2+
K861255	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 6+
K861255	Urine Qualitative Dipstick Blood	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 6+
K861255	Urine Qualitative Dipstick Glucose	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 6+
K861255	Urine Qualitative Dipstick Leukocytes	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 6+
K861255	Urine Qualitative Dipstick Ph	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 6+
K861255	Urine Qualitative Dipstick Protein	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 6+
K861255	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 8+
K861255	Urine Qualitative Dipstick Ketone	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 8+
K861255	Urine Qualitative Dipstick Blood	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 8+
K861255	Urine Qualitative Dipstick Glucose	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 8+
K861255	Urine Qualitative Dipstick Nitrite	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 8+
K861255	Urine Qualitative Dipstick Ph	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 8+
K861255	Urine Qualitative Dipstick Protein	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 8+
K861255	Urine Qualitative Dipstick Urobilinogen	Urinalysis	12/04/2001
QUIDEL QUICKVUE URINCHEK 8+
K861255	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	12/04/2001
HOME DIAGNOSTICS AMERICAN FARE BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/19/2001
HOME DIAGNOSTICS FAMILY PHARMACY BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/19/2001
HOME DIAGNOSTICS HEALTH CARE AMERICA BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/19/2001
HOME DIAGNOSTICS HEB INCONTROL BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/19/2001
HOME DIAGNOSTICS NAVARRO BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/19/2001
HOME DIAGNOSTICS PATHMARK BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/19/2001
POLYMER TECHNOLOGY SYSTEMS BIOSCANNER BEYOND
K013203	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/13/2001
PROVALIS DIAGNOSTICS GLYCOSAL II HBA1C
K011933	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	11/09/2001
BAYER GLUCOMETER DEX 2
K963500	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/07/2001
BIOCARE CORP. URIMATE REAGENT STRIP FOR URINALYSIS
K012829	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	11/06/2001
HOME DIAGNOSTICS HOMEBEST BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/06/2001
HOME DIAGNOSTICS LEADER BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/06/2001
HOME DIAGNOSTICS MEDIC DIRECT BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/06/2001
HOME DIAGNOSTICS PHARMOR BLOOD GLUCOSE SYSTEM - IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/06/2001
UNIPATH CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K013372	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/06/2001
BION DIAGNOSTIC SCIENCES POLY STAT HCG TEST
K012559	Urine hCG By Visual Color Comparison Tests	Endocrinology	10/15/2001
BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST DEVICE
K013194	hCG, Urine	Endocrinology	10/15/2001
BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST STRIP
K013194	hCG, Urine	Endocrinology	10/15/2001
FEMTEK PHEM-ALERT
K012230	Vaginal pH	General Chemistry	10/09/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS HEMOCCULT SENSA
K880499	Fecal Occult Blood	General Chemistry	10/05/2001
BERGEN BRUNSWIG TEST FOR FECAL OCCULT BLOOD
K911075	Fecal Occult Blood	General Chemistry	09/27/2001
CIDA COLOCHECK
K911075	Fecal Occult Blood	General Chemistry	09/27/2001
FISHER HEALTHCARE SURE-VUE FECAL OCCULT BLOOD
K911075	Fecal Occult Blood	General Chemistry	09/27/2001
PSS SELECT OCCULT BLOOD TEST
K911075	Fecal Occult Blood	General Chemistry	09/27/2001
STANBIO HEMA-SCREEN
K911075	Fecal Occult Blood	General Chemistry	09/27/2001
STARLINE COLOSCAN
K911075	Fecal Occult Blood	General Chemistry	09/27/2001
HYPOGUARD DIASCREEN REAGENT STRIPS FOR URINALYSIS
K010973	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	09/21/2001
BAYER GLUCOMETER DEX TEST SENSOR
K012205	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/31/2001
HOME DIAGNOSTICS GAMBRO BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/31/2001
HOME DIAGNOSTICS WALGREENS BLOOD GLUCOSE SYSTEM
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/31/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS GASTROCCULT
K821884	Gastric Occult Blood	General Chemistry	08/30/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS GASTROCCULT
K821884	Gastric pH	General Chemistry	08/30/2001
MEDICAL INSTRUMENTS PRONTO DRY
K002451	Helicobacter Pylori	Bacteriology	08/30/2001
ACON QUIK-CHECK OVULATION PREDICTOR TEST
K012252	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	08/29/2001
CHEMBIO HCG QUICKSTIX
K011551	hCG, Urine	Endocrinology	08/29/2001
DIAGNOSTIC CHEMICALS IMMUNODIP URINARY ALBUMIN SCREEN
K994035	Microalbumin	General Chemistry	08/29/2001
W.H.P.M. WH ACCU TEST PREGNANCY TEST
K012284	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/29/2001
CHEMBIO HCG STAT PAK II
K011550	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/28/2001
HYPOGUARD QUICKTEK BLOOD GLUCOSE METER
K010039	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/28/2001
ACON QUIK-CHECK HOME PREGNANCY TEST
K012215	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/23/2001
ADVANTAGE DIAGNOSTICS ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
K011962	Cannabinoids (THC)	Toxicology / TDM	08/23/2001
ADVANTAGE DIAGNOSTICS ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
K011962	Cocaine Metabolites	Toxicology / TDM	08/23/2001
ROCHE DIAGNOSTICS ACCU-CHEK INFORM METER OTC
K012210	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/23/2001
SA SCIENTIFIC SURE-VUE URINE HCG
K010522	Urine hCG By Visual Color Comparison Tests	Endocrinology	08/23/2001
METRIKA A1C NOW
K000887	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	08/17/2001
EMBRYOTECH LABORATORIES FERTILMARQ HOME DIAGNOSTIC SCREENING TEST FOR MALE INFERTILITY
K011679	Semen	Hematology	08/15/2001
LIFESCAN RUBICON PROTHROMBIN TIME MONITORING SYSTEM  (Professional Use)
K001699	Prothrombin Time (PT)	Hematology	08/06/2001
LIFESCAN RUBICON PROTHROMBIN TIME MONITORING SYSTEM  (Prescription Home Use)
K001699	Prothrombin Time (PT)	Hematology	08/06/2001
BRITE-LIFE BLOOD GLUCOSE SYSTEM IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/03/2001
CVS / PHARMACY BLOOD GLUCOSE SYSTEM IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/03/2001
GOOD NEIGHBOR PHARMACY BLOOD GLUCOSE SYSTEM IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/03/2001
SAV-ON OSCO BY ALBERTSON'S BLOOD GLUCOSE SYSTEM IQ
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/03/2001
OSTEX INTERNATIONAL OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
K011052	Collagen Type I Crosslink, N-Telopeptides (Ntx)	Endocrinology	07/30/2001
KDK CORPORATION LACTATE PRO SYSTEM  (For OTC use)
K980908	Lactic Acid (Lactate)	General Chemistry	07/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9078T)
K010654	Cannabinoids (THC)	Toxicology / TDM	07/27/2001
SA SCIENTIFIC SURE VUE SERUM/URINE HCG
K010593	Urine hCG By Visual Color Comparison Tests	Endocrinology	07/27/2001
QUIDEL QUICKVUE DIPSTICK STREP A  (DIRECT THROAT SWAB)
K011097	Streptococcus, Group A	Bacteriology	07/26/2001
ITC PROTIME MICROCOAGULATION SYSTEM  (Prescription Home Use)
K010599	Prothrombin Time (PT)	Hematology	07/23/2001
ITC PROTIME MICROCOAGULATION SYSTEM  (Professional Use)
K010599	Prothrombin Time (PT)	Hematology	07/23/2001
CHEMBIO SURE CHECK OVULATION PREDICTOR
K010244	Luteinizing Hormone (LH)	Endocrinology	07/20/2001
HOME DIAGNOSTICS MEDICINE SHOPPE BLOOD GLUCOSE SYSTEM
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/20/2001
IVERNESS MEDICAL TECHNOLOGY INDUO BLOOD GLUCOSE METER
K011616	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/20/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9068T)
K010653	Methamphetamines	Toxicology / TDM	07/20/2001
ABB0TT SIGNIFY H. PYLORI WHOLE BLOOD
K990892	Helicobacter Pylori Antibodies	General Immunology	07/17/2001
ICON DS STREP A
K010582	Streptococcus, Group A	Bacteriology	07/17/2001
FOREFRONT DIAGNOSTICS DRUGFREE@HOME THC/COC TEST KIT
K002253	Cannabinoids (THC)	Toxicology / TDM	07/10/2001
FOREFRONT DIAGNOSTICS DRUGFREE@HOME THC/COC TEST KIT
K002253	Cocaine Metabolites	Toxicology / TDM	07/10/2001
ADVANTAGE DIAGNOSTICS ADVANTAGE THC (MARIJUANA) HOME DRUG TEST
K010921	Cannabinoids (THC)	Toxicology / TDM	07/03/2001
HOME DIAGNOSTICS APICAL BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/03/2001
HOME DIAGNOSTICS BROOKS PHARMACY BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/03/2001
HOME DIAGNOSTICS DIABETIC.COM BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/03/2001
HOME DIAGNOSTICS EPIC PHARMACIES BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/03/2001
HOME DIAGNOSTICS FARMACIAS EL AMAL BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/03/2001
HOME DIAGNOSTICS MEDPLUS PHARMACY BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/03/2001
SA SCIENTIFIC SURE-VUE SERUM/URINE HCG-STAT
K990684	hCG, Urine	Endocrinology	07/03/2001
SA SCIENTIFIC HEB ONE-STEP PREGNANCY TEST
K991193	hCG, Urine	Endocrinology	07/02/2001
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MONITORING SYSTEM
K010553	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/22/2001
THERASENSE FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
K992684	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/22/2001
ROCHE DIAGNOSTICS ACCU-CHEK ACTIVE SYSTEM
K011738	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/20/2001
WAMPOLE PREVUE B. BURGDORFERI
K981913	Lyme Disease Antibodies (Borrelia Burgdorferi Abs)	General Immunology	06/19/2001
BIOMEDICAL PRODUCTS DOUBLE-CHEK STRIP URINALYSIS
K993850	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	06/12/2001
SA SCIENTIFIC SAS ULTRA HCG SERUM/URINE
K990684	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/04/2001
GENZYME SIGNIFY HCG URINE/SERUM TEST
K964155	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/02/2001
BAYER MULTISTIX PRO 10LS REAGENT STRIPS
K992257	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	05/01/2001
BAYER MULTISTIX PRO 10LS REAGENT STRIPS
K992257	Urine Qualitative Dipstick Creatinine	Urinalysis	05/01/2001
BAYER MULTISTIX PRO 11 REAGENT STRIPS
K992257	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	05/01/2001
BAYER MULTISTIX PRO 11 REAGENT STRIPS
K992257	Urine Qualitative Dipstick Creatinine	Urinalysis	05/01/2001
BAYER MULTISTIX PRO 7G REAGENT STRIPS
K992257	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	05/01/2001
BAYER MULTISTIX PRO 7G REAGENT STRIPS
K992257	Urine Qualitative Dipstick Creatinine	Urinalysis	05/01/2001
TECO DIAGNOSTICS URS-1K URINE REAGENT STRIPS  (Over-The-Counter)
K003987	Ketone, Urine	General Chemistry	04/30/2001
BECKMAN COULTER ICON DS HCG TEST STRIP  (Urine)
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/23/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9063 T)
K010645	Amphetamines	Toxicology / TDM	04/23/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9073 T)
K010650	Cocaine Metabolites	Toxicology / TDM	04/23/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9083 T)
K010646	Opiates	Toxicology / TDM	04/23/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9133 T)
K010651	Phencyclidine (PCP)	Toxicology / TDM	04/23/2001
CHOLESTECH L.D.X. {Whole Blood}
K991834	Alanine Aminotransferase (ALT) (SGPT)	General Chemistry	04/13/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)
K010655	Amphetamines	Toxicology / TDM	04/04/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)
K010655	Cannabinoids (THC)	Toxicology / TDM	04/04/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)
K010655	Cocaine Metabolites	Toxicology / TDM	04/04/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)
K010655	Opiates	Toxicology / TDM	04/04/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150T)
K010655	Methamphetamine/Amphetamine	Toxicology / TDM	04/04/2001
CYGNUS, INC. GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
P990026	Glucose, Fluid (Approved By Fda For Prescription Home Use)	General Chemistry	03/28/2001
HOME DIAGNOSTICS PRESTIGE IQ BLOOD GLUCOSE SYSTEM
K010403	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/27/2001
ROCHE DIAGNOSTICS ACCU-CHEK ADVANTAGE {ROCHE DIAGNOSTICS ACCU-CHEK COMFORT CURVE TEST STRIP}
K010362	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/27/2001
ROCHE DIAGNOSTICS ACCU-CHEK COMPLETE SYSTEM {ROCHE DIAGNOSTICS ACCU-CHEK COMFORT CURVE TEST STRIP}
K010362	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/27/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS ICON FX STREP A IMMUNOCHEMICAL STREP A ANTIGEN TEST
K960712	Streptococcus, Group A	Bacteriology	03/16/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9068)
K003858	Methamphetamines	Toxicology / TDM	02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)
K003858	Amphetamines	Toxicology / TDM	02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)
K003858	Cannabinoids (THC)	Toxicology / TDM	02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)
K003858	Cocaine Metabolites	Toxicology / TDM	02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)
K003858	Opiates	Toxicology / TDM	02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9150)
K003858	Methamphetamines	Toxicology / TDM	02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9175)
K003858	Cannabinoids (THC)	Toxicology / TDM	02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9175)
K003858	Opiates	Toxicology / TDM	02/27/2001
PHAMATECH AT HOME DRUG TEST (MODEL 9175)
K003858	Methamphetamines	Toxicology / TDM	02/27/2001
BIOMERICA EZ-HCG URINE (PREGNANCY TEST)
K003856	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/26/2001
HOME DIAGNOSTICS GENICARE BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/26/2001
HOME DIAGNOSTICS MEDHOME DIRECT BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/26/2001
HOME DIAGNOSTICS PHARMOR BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/26/2001
HOME DIAGNOSTICS VITALCARE BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/26/2001
LIFESCAN SURESTEP PRO
K970556	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/25/2001
DIAGNOSTICA, INC. EASE-A-CULT SENSITIVE
K002756	Fecal Occult Blood	General Chemistry	02/21/2001
BAYER MICROALBUSTIX REAGENT STRIPS (OTC)
K991315	Microalbumin	General Chemistry	02/14/2001
BAYER MICROALBUSTIX REAGENT STRIPS (OTC)
K991315	Creatinine	General Chemistry	02/14/2001
INTERNATIONAL NEWTECH DEVELOP. URINALYSIS REAGENT STRIP (10 PARAMETERS)
K993850	Urine Qualitative Dipstick Specific Gravity	Urinalysis	02/05/2001
ENTERIX !NSURE FECAL OCCULT BLOOD TEST
K002457	Fecal Occult Blood	General Chemistry	01/31/2001
MEDTEK DIAGNOSTICS INSTACCULT
K002930	Fecal Occult Blood	General Chemistry	01/30/2001
APEX BIOTECHNOLOGY CORP. GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
K002621	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/22/2001
APEX BIOTECHNOLOGY CORP. GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
K002624	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/22/2001
HEALTH CARE AMERICA BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/22/2001
HUMANA BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/22/2001
STC TECHNOLOGIES ORASURE Q.E.D. A-150 SALIVA ALCOHOL TEST
K894001	Alcohol, Saliva	Toxicology / TDM	01/22/2001
VALU-RITE BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/22/2001
WEIS PHARMACY BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	01/22/2001
GENUA MENOPAUSE MONITOR TEST  (Qualitative)
K002450	Follicle Stimulating Hormone (FSH)	Endocrinology	01/12/2001
ACON ONE STEP PREGNANCY TEST STRIP (URINE)
K993203	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/19/2000
KINRAY PREFERRED PLUS BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/19/2000
LIFESCAN SATURN BLOOD GLUCOSE MONITORING TEST STRIP
K001441	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/19/2000
STC TECHNOLOGIES ORASURE Q.E.D. A-350 SALIVA ALCOHOL TEST
K903235	Alcohol, Saliva	Toxicology / TDM	12/19/2000
THERASENSE FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
K000582	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/19/2000
ACCUNATE-CHOICE
K992397	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/13/2000
DISCOUNT DRUG MART FOOD FAIR BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/13/2000
DRUG EMPORIUM BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/13/2000
DUANE READE BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/13/2000
EXPRESS MED BLOOD GLYCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/13/2000
FACT PLUS PRO PREGNANCY TEST
K990576	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/13/2000
FACT PLUS SELECT PREGNANCY TEST
K965184	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/13/2000
GIANT EAGLE BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/13/2000
GOOD NEIGHBOR PHARMACY BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/13/2000
HELENA LABORATORIES COLOSCREEN-ES
K003359	Fecal Occult Blood	General Chemistry	12/13/2000
KERR BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/13/2000
MEDIC BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/13/2000
SENTRY BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/13/2000
SHOP RITE BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	12/13/2000
BECKMAN COULTER INC'S ICON 25 HCG
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/06/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)
K993852	Cannabinoids (THC)	Toxicology / TDM	12/06/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)
K993852	Cocaine Metabolites	Toxicology / TDM	12/06/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)
K993852	Opiates	Toxicology / TDM	12/06/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-OPI-MET)
K993852	Methamphetamines	Toxicology / TDM	12/06/2000
BECKMAN COULTER INC'S ICON 25 HCG
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	12/04/2000
ZYMETX ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES
K982429	Influenza A/B	Virology	12/04/2000
AMERITEK DBEST HCG 2 IU/ML TEST KIT
K001215	Urine hCG By Visual Color Comparison Tests	Endocrinology	11/30/2000
METRIKA DRX HBA1C PRESCRIPTION HOME USE
K000885	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	11/30/2000
BRITE-LIFE BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/29/2000
LIFE MEDICAL BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/29/2000
MEIJER BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/29/2000
SAV-ON OSCO BY ALBERTSON'S BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/29/2000
TRUE CARE BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/29/2000
Metrika DRX Professional Use Hemoglobin A1c Test
K000887	Glycosylated Hemoglobin (Hgb A1c)	General Chemistry	11/27/2000
MEDISENSE SOF-TACT DIABETES MANAGEMENT SYSTEM
K001993	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	11/20/2000
INVERNESS MEDICAL EARLY OVULATION PREDICTOR  (stick)
K002867	Luteinizing Hormone (LH)	Endocrinology	10/23/2000
Quidel Quickvue Influenza A/B
K991633	Influenza A/B	Virology	10/04/2000
LIFESCAN SURESTEP FLEXX BLOOD GLUCOSE MONITORING SYSTEM
K970556	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/18/2000
ACON HCG URINE/SERUM ONE STEP PREGNANCY TEST DEVICE
K993065	Urine hCG By Visual Color Comparison Tests	Endocrinology	09/15/2000
ABBOTT MEDISENSE RELION BLOOD GLUCOSE TEST SYSTEM
K944195	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	09/14/2000
WYNTEK DIAGNOSTICS SIGNIFY MONO TEST  (For whole blood)
K972231	Infectious Mononucleosis Antibodies (Mono)	General Immunology	09/07/2000
Roche Diagnostics CoaguChek S System
K994349	Prothrombin Time (PT)	Hematology	09/06/2000
LIFESCAN ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K002134	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/09/2000
LIFESCAN ONE TOUCH IIB BLOOD GLUCOSE METER {INBIOS INTERNATIONAL, INC. GENERIC BLOOD GLUCOSE TEST STRIP}
K001092	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/01/2000
LIFESCAN ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM {INBIOS INTERNATIONAL, INC. GENERIC BLOOD GLUCOSE TEST STRIP}
K001092	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	08/01/2000
SELFCARE, INC., FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K001427	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	07/27/2000
LIFESTREAM TECHNOLOGIES PERSONAL CHOLESTEROL MONITOR  (For OTC use)
K000610	Cholesterol	General Chemistry	07/19/2000
UNIPATH CLEARPLAN EASY FERTILITY MONITOR
K981207	Ovulation Test (LH) By Visual Color Comparison	Endocrinology	07/17/2000
UNIPATH CLEARPLAN EASY FERTILITY MONITOR
K981207	Estrone-3 Glucuronide	Endocrinology	07/17/2000
TRINITY BIOTECH UNI-GOLD H. PYLORI
K991697	Helicobacter Pylori Antibodies	General Immunology	07/11/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC)
K993663	Cannabinoids (THC)	Toxicology / TDM	07/11/2000
WYNTEK DIAGNOSTICS OSOM ULTRA STREP A
K992658	Streptococcus, Group A	Bacteriology	07/06/2000
POLYMER TECHNOLOGY SYSTEMS, BIOSCANNER  (For OTC use)
K000586	Triglyceride	General Chemistry	06/29/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-MET)
K994138	Cannabinoids (THC)	Toxicology / TDM	06/29/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-MET)
K994138	Cocaine Metabolites	Toxicology / TDM	06/29/2000
WORLDWIDE MEDICAL CORPORATION FIRST CHECK HOME DRUG TEST (THC-COC-MET)
K994138	Methamphetamines	Toxicology / TDM	06/29/2000
WORLDWIDE MEDICAL FIRST CHECK PANEL 2 (THC/COC)
K994139	Cannabinoids (THC)	Toxicology / TDM	06/29/2000
WORLDWIDE MEDICAL FIRST CHECK PANEL 2 (THC/COC)
K994139	Cocaine Metabolites	Toxicology / TDM	06/29/2000
MIZUHO USA ABSOLUTE HCG PREGNANCY TEST
K000844	Urine hCG By Visual Color Comparison Tests	Endocrinology	06/15/2000
HOME DIAGNOSTICS NAVARRO BLOOD GLUCOSE SYSTEM
K992988	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	06/09/2000
QUIDEL QUICKVUE URINE CHECK
K861255	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	05/23/2000
LIFESIGN LLC STATUS STREP A
K983386	Streptococcus, Group A	Bacteriology	05/17/2000
PRINCETON BIOMEDITECH BIOSTREP A
K983386	Streptococcus, Group A	Bacteriology	05/17/2000
WYNTEK DIAGNOSTICS SIGNIFY HCG URINE TEST
K974159	Urine hCG By Visual Color Comparison Tests	Endocrinology	05/02/2000
SA SCIENTIFIC SAS SERUM/URINE HCG
K990684	Urine hCG By Visual Color Comparison Tests	Endocrinology	04/26/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9063)
K994237	Amphetamines	Toxicology / TDM	04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9068)
K994233	Methamphetamines	Toxicology / TDM	04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9073)
K994219	Cocaine Metabolites	Toxicology / TDM	04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9078)
K994220	Cannabinoids (THC)	Toxicology / TDM	04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9083)
K994234	Opiates	Toxicology / TDM	04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9133)
K994236	Phencyclidine (PCP)	Toxicology / TDM	04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9170)
K991641	Cannabinoids (THC)	Toxicology / TDM	04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9170)
K991641	Cocaine Metabolites	Toxicology / TDM	04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9171)
K991824	Opiates	Toxicology / TDM	04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9171)
K991824	Methamphetamines	Toxicology / TDM	04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9175)
K992217	Cannabinoids (THC)	Toxicology / TDM	04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9175)
K992217	Opiates	Toxicology / TDM	04/19/2000
PHAMATECH AT HOME DRUG TEST (MODEL 9175)
K992217	Methamphetamines	Toxicology / TDM	04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150
K982621	Amphetamines	Toxicology / TDM	04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150
K982621	Phencyclidine (PCP)	Toxicology / TDM	04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150
K982621	Cocaine Metabolites	Toxicology / TDM	04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150
K982621	Opiates	Toxicology / TDM	04/19/2000
PHAMATECH QUICKSCREEN AT HOME DRUG TEST MODEL 9149/9150
K982621	Methamphetamines	Toxicology / TDM	04/19/2000
POLYMEDCO POLY STAT A (II)
K973111	Streptococcus, Group A	Bacteriology	04/13/2000
JANT PHARMACAL H. PYLORI
K990892	Helicobacter Pylori Antibodies	General Immunology	04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11
K991927	Urine Qualitative Dipstick Ketone	Urinalysis	04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11
K991927	Urine Dipstick Or Tablet Analytes, Nonautomated	Urinalysis	04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11
K991927	Urine Qualitative Dipstick Bilirubin	Urinalysis	04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11
K991927	Urine Qualitative Dipstick Blood	Urinalysis	04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11
K991927	Urine Qualitative Dipstick Glucose	Urinalysis	04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11
K991927	Urine Qualitative Dipstick Leukocytes	Urinalysis	04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11
K991927	Urine Qualitative Dipstick Nitrite	Urinalysis	04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11
K991927	Urine Qualitative Dipstick Ph	Urinalysis	04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11
K991927	Urine Qualitative Dipstick Protein	Urinalysis	04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11
K991927	Urine Qualitative Dipstick Urobilinogen	Urinalysis	04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11
K991927	Urine Qualitative Dipstick Specific Gravity	Urinalysis	04/03/2000
MACHEREY-NAGEL MEDI TEST COMBI 11
K991927	Urine Qualitative Dipstick Ascorbic Acid	Urinalysis	04/03/2000
POLYMER TECHNOLOGY SYSTEMS, BIOSCANNER TEST STRIPS CHOLESTEROL  (For professional use)
K990247	Cholesterol	General Chemistry	04/03/2000
ROCHE DIAGNOSTICS CORP. ACCU-CHEK ADVANTAGE METER
K000365	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/01/2000
ROCHE DIAGNOSTICS CORP. ACCU-CHEK COMPLETE SYSTEM
K000364	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	04/01/2000
SELFCARE, INC., FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K000583	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	03/15/2000
TECO DIAGNOSTICS URS-1K URINE REAGENT STRIPS
X000002	Urine Qualitative Dipstick Ketone	Urinalysis	03/10/2000
ABBOTT LABORATORIES, MEDISENSE OPTIUM ADVANCED DIABETES MANAGEMENT SYSTEM
K983504	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/25/2000
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K983504	Glucose Monitoring Devices (FDA Cleared/Home Use)	General Chemistry	02/25/2000
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K983504	Ketone, Blood	General Chemistry	02/25/2000
POLYMEDCO POLY STAT HCG
K932635	Urine hCG By Visual Color Comparison Tests	Endocrinology	02/25/2000
AVOCET ACUSURE SYSTEM  (Prescription Home Use)
K994006	Prothrombin Time (PT)	Hematology	02/16/2000
AVOCET AVOSURE PT SYSTEM  (Prescription Home Use)
K991286	Prothrombin Time (PT)	Hematology	02/16/2000
POLYMEDCO POLYSTAT MONO
K973559	Infectious Mononucleosis Antibodies (Mono)	General Immunology	02/14/2000