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Tests Waived by FDA from January 2000 to Present

Tests Waived by FDA from January 2000 to Present

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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.

Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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)
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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)
K022312 Phosphorus 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)
K992140 potassium General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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)
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 Renal Function Panel} (Whole blood)
K022312 Phosphorus General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole blood)
K950164 Calcium, Total General Chemistry 12/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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)
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 {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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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)
K993211 Albumin General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole blood)
K993211 Sodium 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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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 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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole blood)
K942782 Urea (BUN) 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 xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole blood)
K934592 Uric Acid 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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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)
K950164 Calcium, Total General Chemistry 03/14/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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
Document Test System Name
Analyte		 Analyte Specialty Effective Date
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/