CLIA - Tests waived by FDA from January 2000 to present

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

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Show All Test Systems Download Files | More About CLIA Document Test System Name Analyte Analyte Specialty Effective Date Cardinal Health Leader Blood Glucose Monitoring System   K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/13/2009 CLIAwaived, Inc. Rapid Fecal Occult Blood Test   K061065 Fecal Occult Blood General Chemistry 11/09/2009 Princeton BioMeditech BioSign H. pylori WB {OSOM H. pylori} ((for whole blood) K980798 Helicobacter Pylori Antibodies General Immunology 11/09/2009 Arkray ReliOn Confirm Blood Glucose Monitoring System   K073416 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/30/2009 Arkray, GLUCOCARD VITAL Blood Glucose Monitoring System   K091102 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/30/2009 Nova Biomedical Corp. StatStrip Xpress Glucose Hosptial Meter   K070960 Glucose Monitoring Devices (Prescription Use Only) General Chemistry 10/30/2009 Acon Mission U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Ketone Urinalysis 10/28/2009 Acon Mission U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Bilirubin Urinalysis 10/28/2009 Acon Mission U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Blood Urinalysis 10/28/2009 Acon Mission U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Glucose Urinalysis 10/28/2009 Acon Mission U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Leukocytes Urinalysis 10/28/2009 Acon Mission U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Nitrite Urinalysis 10/28/2009 Acon Mission U120 Urine Analyzer   K070929 Urine Qualitative Dipstick pH Urinalysis 10/28/2009 Acon Mission U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Protein Urinalysis 10/28/2009 Acon Mission U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/28/2009 Acon Mission U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/28/2009 Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer   K070929 Urine Qualitative Dipstick Ketone Urinalysis 10/28/2009 Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer   K070929 Urine Qualitative Dipstick Bilirubin Urinalysis 10/28/2009 Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer   K070929 Urine Qualitative Dipstick Blood Urinalysis 10/28/2009 Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer   K070929 Urine Qualitative Dipstick Glucose Urinalysis 10/28/2009 Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer   K070929 Urine Qualitative Dipstick Leukocytes Urinalysis 10/28/2009 Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer   K070929 Urine Qualitative Dipstick Nitrite Urinalysis 10/28/2009 Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer   K070929 Urine Qualitative Dipstick pH Urinalysis 10/28/2009 Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer   K070929 Urine Qualitative Dipstick Protein Urinalysis 10/28/2009 Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer   K070929 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/28/2009 Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer   K070929 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/28/2009 RefuAH U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Ketone Urinalysis 10/28/2009 RefuAH U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Bilirubin Urinalysis 10/28/2009 RefuAH U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Blood Urinalysis 10/28/2009 RefuAH U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Glucose Urinalysis 10/28/2009 RefuAH U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Leukocytes Urinalysis 10/28/2009 RefuAH U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Nitrite Urinalysis 10/28/2009 RefuAH U120 Urine Analyzer   K070929 Urine Qualitative Dipstick pH Urinalysis 10/28/2009 RefuAH U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Protein Urinalysis 10/28/2009 RefuAH U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/28/2009 RefuAH U120 Urine Analyzer   K070929 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/28/2009 Genzyme Diagnostics OSOM ImmunoDip Urinary Albumin Test   K022538 Albumin, Urinary General Chemistry 10/26/2009 Fifty 50 Medical, Fifty 50 Glucose Monitoring System 2.0   K083468 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/14/2009 Major Biosystem Corp. AP-1000 Blood Glucose Monitoring System   K090389 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/14/2009 Fora Care Inc. FORA G90 Blood Glucose Monitoring System   K091898 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/30/2009 Fora Care Inc. U-Right TD-4234 Blood Glucose Monitoring System   K091898 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Amphetamines Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Cannabinoids (THC) Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Phencyclidine (PCP) Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Cocaine Metabolites Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Opiates Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Methadone Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Methamphetamines Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Benzodiazepines Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Barbiturates Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Morphine Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Tricyclic Antidepressants Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cards   K091588 Oxycodone Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Amphetamines Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Cannabinoids (THC) Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Phencyclidine (PCP) Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Cocaine Metabolites Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Opiates Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Methadone Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Methamphetamines Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Benzodiazepines Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Barbiturates Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Morphine Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Tricyclic Antidepressants Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/30/2009 UCP Biosciences, Inc. UCP Home Drug Screening Test Cups   K091588 Oxycodone Toxicology / TDM 09/30/2009 CLIA waived inc Rapid STREP A Test   K023270 Streptococcus, Group A Bacteriology 09/15/2009 Fora Care Inc. U-Right TD-4250 Blood Glucose Monitoring System   K083570 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/14/2009 Fora Care Inc. U-Right TD-4249 Blood Glucose Monitoring System   K083570 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/14/2009 Siemens Clinitek 50 Urine Chemistry Analyzer   K960546 Urine Qualitative Dipstick Ketone Urinalysis 09/14/2009 Siemens Clinitek 50 Urine Chemistry Analyzer   K960546 Urine Qualitative Dipstick Bilirubin Urinalysis 09/14/2009 Siemens Clinitek 50 Urine Chemistry Analyzer   K960546 Urine Qualitative Dipstick Blood Urinalysis 09/14/2009 Siemens Clinitek 50 Urine Chemistry Analyzer   K960546 Urine Qualitative Dipstick Glucose Urinalysis 09/14/2009 Siemens Clinitek 50 Urine Chemistry Analyzer   K960546 Urine Qualitative Dipstick Leukocytes Urinalysis 09/14/2009 Siemens Clinitek 50 Urine Chemistry Analyzer   K960546 Urine Qualitative Dipstick Nitrite Urinalysis 09/14/2009 Siemens Clinitek 50 Urine Chemistry Analyzer   K960546 Urine Qualitative Dipstick pH Urinalysis 09/14/2009 Siemens Clinitek 50 Urine Chemistry Analyzer   K960546 Urine Qualitative Dipstick Protein Urinalysis 09/14/2009 Siemens Clinitek 50 Urine Chemistry Analyzer   K960546 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/14/2009 Siemens Clinitek 50 Urine Chemistry Analyzer   K960546 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/14/2009 Siemens Clinitek 50 Urine Chemistry Analyzer   K972706 Microalbumin General Chemistry 09/14/2009 Siemens Clinitek 50 Urine Chemistry Analyzer   K972706 Creatinine General Chemistry 09/14/2009 Bayer Contour USB Glucose Monitoring System   K091820 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2009 Excel Medical Group Bio View hCG Pregnancy Serum/Urine Cassette and Dipstick Tests   K071030 Urine hCG By Visual Color Comparison Tests Endocrinology 09/09/2009 GERMAINE LABORATORIES AimStep Immunological Fecal Occult Blood Test (iFOBT)   K063693 Fecal Occult Blood General Chemistry 09/09/2009 PSS CONSULT Diagnostic Occult Blood Test   K911075 Fecal Occult Blood General Chemistry 09/09/2009 PSS CONSULT diagnostics Occult Blood Test-ES   K003359 Fecal Occult Blood General Chemistry 09/09/2009 SCI International, Inc. Baby Test Pregnancy Test Cassette Format   K050741 Urine hCG By Visual Color Comparison Tests Endocrinology 09/09/2009 SCI International, Inc. U-Check Pregnancy Test Cassette Format   K050741 Urine hCG By Visual Color Comparison Tests Endocrinology 09/09/2009 Specialty Medical Supplies Vocal Point Blood Glucose Monitoring System   K083570 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2009 Wiener Laboratories Urine Strip   K083724 Urine Qualitative Dipstick Ketone Urinalysis 09/09/2009 Wiener Laboratories Urine Strip   K083724 Urine Qualitative Dipstick Bilirubin Urinalysis 09/09/2009 Wiener Laboratories Urine Strip   K083724 Urine Qualitative Dipstick Blood Urinalysis 09/09/2009 Wiener Laboratories Urine Strip   K083724 Urine Qualitative Dipstick Glucose Urinalysis 09/09/2009 Wiener Laboratories Urine Strip   K083724 Urine Qualitative Dipstick Leukocytes Urinalysis 09/09/2009 Wiener Laboratories Urine Strip   K083724 Urine Qualitative Dipstick Nitrite Urinalysis 09/09/2009 Wiener Laboratories Urine Strip   K083724 Urine Qualitative Dipstick pH Urinalysis 09/09/2009 Wiener Laboratories Urine Strip   K083724 Urine Qualitative Dipstick Protein Urinalysis 09/09/2009 Wiener Laboratories Urine Strip   K083724 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/09/2009 Wiener Laboratories Urine Strip   K083724 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/09/2009 Wiener Laboratories Urine Strip   K083724 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 09/09/2009 Guangzhou Wondfo Biotech One Step HCG Urine/Serum Test   K072500 Urine hCG By Visual Color Comparison Tests Endocrinology 09/03/2009 Arkray USA Inc. Assure Pro Blood Glucose Monitoring System   K090332 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/01/2009 EPS Bio Technology Corp. EasyPlus mini R13N Self-Monitoring Blood Glucose System   K091481 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/01/2009 Omnis Health Embrace No Code Blood Glucose Monitoring System   K090043 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/01/2009 Sacks Medical Corp., RefuAH Plus Blood Glucose Monitoring System   K090057 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/01/2009 Sacks Medical Corporation RefuAH Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Ketone Urinalysis 08/24/2009 Sacks Medical Corporation RefuAH Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 08/24/2009 Sacks Medical Corporation RefuAH Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Blood Urinalysis 08/24/2009 Sacks Medical Corporation RefuAH Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Glucose Urinalysis 08/24/2009 Sacks Medical Corporation RefuAH Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 08/24/2009 Sacks Medical Corporation RefuAH Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Nitrite Urinalysis 08/24/2009 Sacks Medical Corporation RefuAH Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick pH Urinalysis 08/24/2009 Sacks Medical Corporation RefuAH Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Protein Urinalysis 08/24/2009 Sacks Medical Corporation RefuAH Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 08/24/2009 Sacks Medical Corporation RefuAH Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 08/24/2009 Sacks Medical Corporation RefuAH Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 08/24/2009 BinaxNOW Influenza A & B Test   K092223 Influenza A/B Virology 08/18/2009 Diagnostic Test Group, Clarity Plus Blood Glucose Monitoring System   K090057 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2009 Pro-Advantage by NDC H. Pylori Device {Whole Blood}  K024350 Helicobacter Pylori Antibodies General Immunology 08/07/2009 Fora Care Inc. U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System   K090188 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/16/2009 Fora Care Inc., FORA V12 Blood Glucose Monitoring System   K090404 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/16/2009 Fora Care, Inc., FORA V10 Blood Glucose Monitoring System   K090404 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/16/2009 ProAdvantage by NDC Infectious Mononucleosis Test Device (Whole Blood Only)   K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 07/16/2009 U.S. Diagnostics Inc. ACURA Blood Glucose Monitoring System   K083468 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/16/2009 BTNX Inc. Rapid Response hCG Pregnancy Serum/Urine Test Strip   K974060 Urine hCG By Visual Color Comparison Tests Endocrinology 07/01/2009 Inverness Medical Innovations Signify ER Drug Screen   K041685 Amphetamines Toxicology / TDM 07/01/2009 Inverness Medical Innovations Signify ER Drug Screen   K041685 Cannabinoids (THC) Toxicology / TDM 07/01/2009 Inverness Medical Innovations Signify ER Drug Screen   K041685 Phencyclidine (PCP) Toxicology / TDM 07/01/2009 Inverness Medical Innovations Signify ER Drug Screen   K041685 Cocaine Metabolites Toxicology / TDM 07/01/2009 Inverness Medical Innovations Signify ER Drug Screen   K041685 Opiates Toxicology / TDM 07/01/2009 Inverness Medical Innovations Signify ER Drug Screen   K041685 Propoxyphene Toxicology / TDM 07/01/2009 Inverness Medical Innovations Signify ER Drug Screen   K041685 Benzodiazepines Toxicology / TDM 07/01/2009 Inverness Medical Innovations Signify ER Drug Screen   K041685 Barbiturates Toxicology / TDM 07/01/2009 Inverness Medical Innovations Signify ER Drug Screen   K041685 Tricyclic Antidepressants Toxicology / TDM 07/01/2009 Inverness Medical Innovations Signify ER Drug Screen   K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/01/2009 Inverness Medical Innovations Signify ER Drug Screen   K041685 Oxycodone Toxicology / TDM 07/01/2009 Inverness Medical Innovations Signify hCG Urine Dipstick   K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 07/01/2009 National Distribution and Contracting Inc., Pro Advantage by NDC Urine/Serum Pregnancy Cassette Device   K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 07/01/2009 Turklab Rapidan Optima Early Test One Step hCG Urine Pregnancy Test for Home Use   K081150 Urine hCG By Visual Color Comparison Tests Endocrinology 07/01/2009 Turklab Toyo Diagnostics One Step hCG Urine Pregnancy Cassette Test   K081150 Urine hCG By Visual Color Comparison Tests Endocrinology 07/01/2009 Turklab Toyo Diagnostics One Step hCG Urine Pregnancy Strip Test for Home Use   K081150 Urine hCG By Visual Color Comparison Tests Endocrinology 07/01/2009 All Medicus Gluco Dr. Plus+ Blood Glucose Monitoring System   K082328 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/12/2009 Early Detect Inc., EarlyDETECT Pro hCG Urine pregnancy test card   K020968 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2009 Early Detect Inc., EarlyDETECT Pro hCG Urine pregnancy test strip   K020968 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2009 Fora Care FORA V22 Blood Glucose Monitoring System   K081609 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/12/2009 Fora Care Inc. U-Right TD-4225 Blood Glucose Monitoring System   K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/12/2009 Stanbio HemoPoint H2 DM Hemoglobin Measurement System {with Data Management}  K090093 Hemoglobin Hematology 06/12/2009 Diagnostic Devices Prodigy AutoCode Talking Blood Glucose Monitoring System   K073118 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/08/2009 Diagnostic Devices Prodigy Pocket Blood Glucose Monitoring System   K073118 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/08/2009 Diagnostic Devices Prodigy Voice Talking Blood Glucose Monitoring System   K073118 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/08/2009 National Distribution and Contracting Inc., Pro Advantage by NDC Urine Pregnancy Cassette Device   K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 06/08/2009 Tyson Bioresearch Inc. Diachex+ Pro Blood Glucose Monitoring System   K090629 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/08/2009 Tyson Bioresearch Inc. Easy Step Blood Glucose Monitoring System   K090629 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/08/2009 Abbott OptiumEZ Blood Glucose Monitoring System   K081975 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2009 CLIAwaived INC. Thyroid Test Rapid TSH Cassette  (Whole Blood) K990658 Thyroid Stimulating Hormone (TSH) Endocrinology 06/03/2009 Fora Care Inc. FORA V10 Blood Glucose Monitoring System   K081715 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2009 Fora Care Inc. FORA G30 Blood Glucose Monitoring System   K090187 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/29/2009 EarlyDETECT H. PYLORI WHOLE BLOOD RAPID TEST   K024360 Helicobacter Pylori Bacteriology 05/21/2009 IMI Signify Strep A Dipstick {Inverness Medical Innovations}  K010582 Streptococcus, Group A Bacteriology 05/21/2009 Inverness Medical SIGNIFY H. PYLORI WHOLE BLOOD   K024350 Helicobacter Pylori Antibodies General Immunology 05/21/2009 Inverness Medical Signify Strep A Cassette {Inverness Medical Innovations}  K031784 Streptococcus, Group A Bacteriology 05/21/2009 Twin Spirit, Inc. DrugSmart Cup   K082898 Amphetamines Toxicology / TDM 05/11/2009 Twin Spirit, Inc. DrugSmart Cup   K082898 Cannabinoids (THC) Toxicology / TDM 05/11/2009 Twin Spirit, Inc. DrugSmart Cup   K082898 Phencyclidine (PCP) Toxicology / TDM 05/11/2009 Twin Spirit, Inc. DrugSmart Cup   K082898 Cocaine Metabolites Toxicology / TDM 05/11/2009 Twin Spirit, Inc. DrugSmart Cup   K082898 Opiates Toxicology / TDM 05/11/2009 Twin Spirit, Inc. DrugSmart Cup   K082898 Methadone Toxicology / TDM 05/11/2009 Twin Spirit, Inc. DrugSmart Cup   K082898 Methamphetamines Toxicology / TDM 05/11/2009 Twin Spirit, Inc. DrugSmart Cup   K082898 Benzodiazepines Toxicology / TDM 05/11/2009 Twin Spirit, Inc. DrugSmart Cup   K082898 Barbiturates Toxicology / TDM 05/11/2009 Twin Spirit, Inc. DrugSmart Cup   K082898 Tricyclic Antidepressants Toxicology / TDM 05/11/2009 Twin Spirit, Inc. DrugSmart Cup   K082898 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/11/2009 Twin Spirit, Inc. DrugSmart Cup   K082898 Oxycodone Toxicology / TDM 05/11/2009 All Medicus GlucoDr auto Blood Glucose Test System   K083628 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/07/2009 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II   K050878 Amphetamines Toxicology / TDM 04/30/2009 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II   K050878 Cannabinoids (THC) Toxicology / TDM 04/30/2009 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II   K050878 Phencyclidine (PCP) Toxicology / TDM 04/30/2009 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II   K050878 Cocaine Metabolites Toxicology / TDM 04/30/2009 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II   K050878 Opiates Toxicology / TDM 04/30/2009 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II   K050878 Methamphetamine/Amphetamine Toxicology / TDM 04/30/2009 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z- Split Key Cup II   K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 04/30/2009 Acon Laboratories, On-Call Plus Blood Glucose Monitoring System   K090057 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/30/2009 BTNX Inc. Rapid Response hCG Pregnancy Test (Midstream)   K974059 Urine hCG By Visual Color Comparison Tests Endocrinology 04/30/2009 Home Diagnostics, TRUEbalance Blood Glucose Monitoring System   K090495 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/30/2009 Inverness Medical Innovations Signify hCG Combo Cassette   K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 04/30/2009 The Kroger Co. Kroger Blood Glucose Monitoring System   K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/30/2009 Abbott ReliOn Ultima Blood Glucose Monitoring System   K083223 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/22/2009 AgaMatrix WaveSense Presto Pro Blood Glucose Monitoring System   K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/22/2009 National Diagnostic Products Betachek Blood Glucose (Sugar) Test   K062187 Whole Blood Qualitative Dipstick Glucose General Chemistry 04/22/2009 Fora Care Inc. FORA V12 No-Coding Blood Glucose Monitoring System   K090536 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/16/2009 Acceava Mono II  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 04/14/2009 CLIAwaived Inc. Pregnancy Combo Test (Cassette)   K984077 Urine hCG By Visual Color Comparison Tests Endocrinology 04/06/2009 CLIAwaived Inc. Pregnancy Combo Test (Dip-Strip)   K984080 Urine hCG By Visual Color Comparison Tests Endocrinology 04/06/2009 Acceava Strep A Twist Rapid Test {Streptococcus, Group A}  K010582 Streptococcus, Group A Bacteriology 04/01/2009 Consult Diagnostics STREP A RAPID Dipstick {Streptococcuc, Group A}  K010582 Streptococcus, Group A Bacteriology 04/01/2009 MEC Dynamics Avie A1c Test System   K081269 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 04/01/2009 Amerifit Inc Azo Test Strips Urinary Tract Infection Test   K063295 Nitrite, Urine General Chemistry 03/16/2009 Amerifit Inc Azo Test Strips Urinary Tract Infection Test   K063295 Leukocyte Esterase, Urinary Urinalysis 03/16/2009 BTNX Inc. Rapid Response hCG Pregnancy Test Cassette Format   K050741 Urine hCG By Visual Color Comparison Tests Endocrinology 03/16/2009 BTNX Inc. Rapid Response Pregnancy Test Strip Format   K951705 Urine hCG By Visual Color Comparison Tests Endocrinology 03/16/2009 Lil' Drug Store Products Inc. Vagi-Screen Vaginal Health Test   X080117 pH General Chemistry 03/16/2009 MACHEREY-NAGEL Medi-Test Glucose   K991927 Urine Qualitative Dipstick Glucose Urinalysis 03/16/2009 Innovacon, Inc. One Step hCG Single Test Card   K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 03/12/2009 PSS World Medical, Inc. Consult Diagnostics hCG Combo Cassette   K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 03/12/2009 Amedica Biotech Amedica Drug Screen Test Cup   K082898 Amphetamines Toxicology / TDM 03/10/2009 Amedica Biotech Amedica Drug Screen Test Cup   K082898 Cannabinoids (THC) Toxicology / TDM 03/10/2009 Amedica Biotech Amedica Drug Screen Test Cup   K082898 Phencyclidine (PCP) Toxicology / TDM 03/10/2009 Amedica Biotech Amedica Drug Screen Test Cup   K082898 Cocaine Metabolites Toxicology / TDM 03/10/2009 Amedica Biotech Amedica Drug Screen Test Cup   K082898 Opiates Toxicology / TDM 03/10/2009 Amedica Biotech Amedica Drug Screen Test Cup   K082898 Methadone Toxicology / TDM 03/10/2009 Amedica Biotech Amedica Drug Screen Test Cup   K082898 Methamphetamines Toxicology / TDM 03/10/2009 Amedica Biotech Amedica Drug Screen Test Cup   K082898 Benzodiazepines Toxicology / TDM 03/10/2009 Amedica Biotech Amedica Drug Screen Test Cup   K082898 Barbiturates Toxicology / TDM 03/10/2009 Amedica Biotech Amedica Drug Screen Test Cup   K082898 Tricyclic Antidepressants Toxicology / TDM 03/10/2009 Amedica Biotech Amedica Drug Screen Test Cup   K082898 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/10/2009 Amedica Biotech Amedica Drug Screen Test Cup   K082898 Oxycodone Toxicology / TDM 03/10/2009 EarlyDetect Pro Influenza A Test   K041441 Influenza A Virology 03/10/2009 EarlyDetect Pro Influenza B Test   K041439 Influenza B Virology 03/10/2009 PSS World Medical, Inc. Consult Diagnostics hCG Dipstick   K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 03/10/2009 PSS World Medical, Inc. 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Urocheck 9 Urine Reagent Strips for Urinalysis   K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008 Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis   K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 11/21/2008 Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis   K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008 Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis   K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008 Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis   K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008 Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis   K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008 Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis   K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008 Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis   K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/21/2008 Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis   K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/21/2008 Diagnostic Test Group Clarity Urocheck Blood Urine Reagent Strips for Urinalysis   K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008 Abbott i-STAT 6+ Cartridge  (Venous Whole blood) K053110 Hemoglobin Hematology 11/13/2008 Abbott i-STAT 6+ Cartridge  (Venous Whole blood) K053110 Glucose General Chemistry 11/13/2008 Abbott i-STAT 6+ Cartridge  (Venous Whole blood) K053110 Sodium General Chemistry 11/13/2008 Abbott i-STAT 6+ Cartridge  (Venous Whole blood) K053110 potassium General Chemistry 11/13/2008 Abbott i-STAT 6+ Cartridge  (Venous Whole blood) K053110 Urea (BUN) General Chemistry 11/13/2008 Abbott i-STAT 6+ Cartridge  (Venous Whole blood) K053110 chloride General Chemistry 11/13/2008 Abbott 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Hematocrit Hematology 11/13/2008 Abbott i-STAT G Cartridge  (Venous Whole blood) K053110 Glucose General Chemistry 11/13/2008 Fora Care Inc. FORA D-10 Blood Glucose plus Blood Pressure Monitoring System   K081714 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/13/2008 Nova Biomedical Nova Gold Blood Glucose Monitoring System   K070255 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/13/2008 Siemens DCA 2000 analyzer   K951361 Glycated Hemoglobin, Total General Chemistry 11/13/2008 Siemens DCA 2000+ analyzer   K951361 Glycated Hemoglobin, Total General Chemistry 11/13/2008 Common Sense Ltd. Norma-Sense Vaginal Discharge pH Test   X070057 pH, Urine General Chemistry 11/04/2008 IM Diagnostics, Inc. IM Maxie 2 hCG Pregnancy Urine Cassette and Dipstick Tests   K070921 Urine hCG By Visual Color Comparison Tests Endocrinology 11/04/2008 Mossman Associates, Inc. NicCheck I Test Strips   K963733 Nicotine And/Or Metabolites Toxicology / TDM 11/04/2008 Wako APOLOWAKO Analyzer {Whole Blood}  K080123 Glucose General Chemistry 10/31/2008 Wako APOLOWAKO Analyzer {Whole Blood}  K080123 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 10/31/2008 Wako APOLOWAKO Analyzer  (Whole Blood) K080125 Triglyceride General Chemistry 10/31/2008 Wako APOLOWAKO Analyzer  (Whole Blood) K080125 Cholesterol General Chemistry 10/31/2008 IM Diagnostics, Inc. IM Confirms II plus hCG Pregnancy Serum/Urine Cassette and Dipstick Tests   K071030 Urine hCG By Visual Color Comparison Tests Endocrinology 10/28/2008 Arkray USA, Inc. GLUCOCARD 01-mini Blood Glucose Monitoring System   K082417 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008 i-SENS, Inc. CareSens II Blood Glucose Monitoring System   K080923 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008 i-SENS, Inc. CareSens POP Blood Glucose Monitoring System   K080923 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008 LifeScan OneTouch Vita Blood Glucose Monitoring System   K082513 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008 Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System   K080960 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/17/2008 Abbott Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System   K080960 Ketone, Blood General Chemistry 10/17/2008 Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)   K061559 Urine Qualitative Dipstick Ketone Urinalysis 10/17/2008 Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)   K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 10/17/2008 Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)   K061559 Urine Qualitative Dipstick Blood Urinalysis 10/17/2008 Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)   K061559 Urine Qualitative Dipstick Glucose Urinalysis 10/17/2008 Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)   K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 10/17/2008 Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)   K061559 Urine Qualitative Dipstick Nitrite Urinalysis 10/17/2008 Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)   K061559 Urine Qualitative Dipstick pH Urinalysis 10/17/2008 Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)   K061559 Urine Qualitative Dipstick Protein Urinalysis 10/17/2008 Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)   K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/17/2008 Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)   K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/17/2008 Acon Laboratories, Inc. Mission Urinalysis Reagent Strips (Urine)   K061559 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 10/17/2008 Arkray USA, Inc. Assure 4 Blood Glucose Monitoring System   K070088 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/17/2008 BTNX Rapid Response 10-SG Urinalysis Reagent Strip   K970250 Urine Qualitative Dipstick Ketone Urinalysis 10/17/2008 BTNX Rapid Response 10-SG Urinalysis Reagent Strip   K970250 Urine Qualitative Dipstick Bilirubin Urinalysis 10/17/2008 BTNX Rapid Response 10-SG Urinalysis Reagent Strip   K970250 Urine Qualitative Dipstick Blood Urinalysis 10/17/2008 BTNX Rapid Response 10-SG Urinalysis Reagent Strip   K970250 Urine Qualitative Dipstick Glucose Urinalysis 10/17/2008 BTNX Rapid Response 10-SG Urinalysis Reagent Strip   K970250 Urine Qualitative Dipstick Leukocytes Urinalysis 10/17/2008 BTNX Rapid Response 10-SG Urinalysis Reagent Strip   K970250 Urine Qualitative Dipstick Nitrite Urinalysis 10/17/2008 BTNX Rapid Response 10-SG Urinalysis Reagent Strip   K970250 Urine Qualitative Dipstick pH Urinalysis 10/17/2008 BTNX Rapid Response 10-SG Urinalysis Reagent Strip   K970250 Urine Qualitative Dipstick Protein Urinalysis 10/17/2008 BTNX Rapid Response 10-SG Urinalysis Reagent Strip   K970250 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/17/2008 BTNX Rapid Response 10-SG Urinalysis Reagent Strip   K970250 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/17/2008 Consult diagnostics Urine Analyzer   K050801 Urine Qualitative Dipstick Ketone Urinalysis 10/17/2008 Consult diagnostics Urine Analyzer   K050801 Urine Qualitative Dipstick Bilirubin Urinalysis 10/17/2008 Consult diagnostics Urine Analyzer   K050801 Urine Qualitative Dipstick Blood Urinalysis 10/17/2008 Consult diagnostics Urine Analyzer   K050801 Urine Qualitative Dipstick Glucose Urinalysis 10/17/2008 Consult diagnostics Urine Analyzer   K050801 Urine Qualitative Dipstick Leukocytes Urinalysis 10/17/2008 Consult diagnostics Urine Analyzer   K050801 Urine Qualitative Dipstick Nitrite Urinalysis 10/17/2008 Consult diagnostics Urine Analyzer   K050801 Urine Qualitative Dipstick pH Urinalysis 10/17/2008 Consult diagnostics Urine Analyzer   K050801 Urine Qualitative Dipstick Protein Urinalysis 10/17/2008 Consult diagnostics Urine Analyzer   K050801 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/17/2008 Consult diagnostics Urine Analyzer   K050801 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/17/2008 Vertex Diagnostics UltraTRAK PRO Blood Glucose Monitoring System   K082618 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/17/2008 Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM100   K081451 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/25/2008 QUIDEL QUICKVUE DIPSTICK STREP A  (DIRECT THROAT SWAB) K011097 Streptococcus, Group A Bacteriology 09/25/2008 Quidel QuickVue In-Line Strep A  (direct from throat swab) K934484 Streptococcus, Group A Bacteriology 09/25/2008 Quidel QuickVue Influenza A+B Test   K053146 Influenza A/B Virology 09/25/2008 Quidel QuickVue Influenza Test   K991633 Influenza A/B Virology 09/25/2008 Quidel QuickVue RSV Test   K061008 Respiratory Syncytial Virus Virology 09/25/2008 Quidel QuickVue RSV Test   K070747 Respiratory Syncytial Virus Virology 09/25/2008 Common Sense Ltd. VA-SENSE Kit   X070058 Vaginal pH General Chemistry 09/18/2008 EPS Bio Technology EasyPlus mini EasyMax self monitoring blood glucose system   K082121 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008 Fora Comfort 2 in 1 TD-3250C Blood Glucose and Blood Pressure Monitoring System   K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008 Fora Comfort 2 in 1 TD-3260 Blood Glucose Plus Blood Pressure Monitoring System   K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K052719 Urine Qualitative Dipstick Ketone Urinalysis 09/18/2008 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K052719 Urine Qualitative Dipstick Bilirubin Urinalysis 09/18/2008 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K052719 Urine Qualitative Dipstick Blood Urinalysis 09/18/2008 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K052719 Urine 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System   K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008 Taidoc Clever Chek TD-3250D Blood Glucose and Blood Pressure Monitoring System   K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008 Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM110   K081450 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/12/2008 Andon Health Co., Ltd., andon AG-605 Blood Glucose Monitoring System   K073030 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/04/2008 Andon Health Co., Ltd., andon AG-606 Blood Glucose Monitoring System   K073030 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/04/2008 Home Diagnostics TRUEresult Blood Glucose Monitoring System   K080641 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/20/2008 Acon Laboratories Mission UTI Urinary Tract Infection Test Strips   K063295 Nitrite, Urine General Chemistry 08/18/2008 Acon Laboratories Mission UTI Urinary Tract Infection Test Strips   K063295 Leukocyte Esterase, Urinary Urinalysis 08/18/2008 American Bio Medica Rapid TOX   K053359 Amphetamines Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Cannabinoids (THC) Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Phencyclidine (PCP) Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Cocaine Metabolites Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Opiates Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Methadone Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Propoxyphene Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Methamphetamines Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Benzodiazepines Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Barbiturates Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Tricyclic Antidepressants Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Oxycodone Toxicology / TDM 08/18/2008 American Bio Medica Rapid TOX   K053359 Buprenorphine Toxicology / TDM 08/18/2008 Home Diagnostics TRUE2go Blood Glucose Monitoring System   K080710 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/15/2008 Inverness Medical Acceava hCG Urine II   K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 08/14/2008 Home Diagnostics, Home Care Delivered TrueTrack Smart System Blood Glucose Monitoring System   K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008 Home Diagnostics, Moore Medical TrueTrack Blood Glucose Monitoring System   K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2008 Home Diagnostics, TrueTrack for Rite Aid Blood Glucose Monitoring 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FORA TD-3224 Blood Glucose Plus Blood Pressure Monitoring System   K081714 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008 Gluco Perfect LLC, Perfect Mini Blood Glucose Monitoring System   K052818 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008 BTNX Inc. Rapid Response Immunological Fecal Occult Blood Test (IFOBT)   K061065 Fecal Occult Blood General Chemistry 07/22/2008 Healthcare Provider Direct OneStep Fecal Occult Blood (FOB) Screen Card Test   K063693 Fecal Occult Blood General Chemistry 07/22/2008 Roche Diagnostics ACCU-CHEK Compact Plus Blood Glucose Meter   K081389 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/22/2008 Arkray USA, Inc. GLUCOCARD 01 Blood Glucose Monitoring System   K073416 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/17/2008 Henry Schein One Step+ Strep A Dipstick Test   K010582 Streptococcus, Group A Bacteriology 07/17/2008 Germaine Laboratories Inc. AimStrip Urine Reagent Strips   K051727 Urine Qualitative Dipstick Ketone Urinalysis 07/14/2008 Germaine Laboratories Inc. AimStrip Urine Reagent Strips   K051727 Urine Qualitative Dipstick Glucose Urinalysis 07/14/2008 Germaine Laboratories Inc. AimStrip Urine Reagent Strips   K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 07/14/2008 Germaine Laboratories Inc. AimStrip Urine Reagent Strips   K051727 Urine Qualitative Dipstick Nitrite Urinalysis 07/14/2008 Germaine Laboratories, Inc. AimStrip Urine Reagent Strips   K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 07/14/2008 Germaine Laboratories, Inc. AimStrip Urine Reagent Strips   K051727 Urine Qualitative Dipstick Blood Urinalysis 07/14/2008 Germaine Laboratories, Inc. AimStrip Urine Reagent Strips   K051727 Urine Qualitative Dipstick Protein Urinalysis 07/14/2008 Germaine Laboratories, Inc. AimStrip Urine Reagent Strips   K051727 Urine Qualitative Dipstick pH Urinalysis 07/14/2008 Germaine Laboratories, Inc. AimStrip Urine Reagent Strips   K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/14/2008 Germaine Laboratories, Inc. AimStrip Urine Reagent Strips   K051727 Urine Qualitative Dipstick Specific Gravity Urinalysis 07/14/2008 Inverness Medical Acceava hCG Basic II   K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 07/14/2008 Inverness Medical Acceava hCG Combo II   K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 07/14/2008 BECKMAN COULTER HEMOCCULT ICT   K080812 Fecal Occult Blood General Chemistry 07/01/2008 Germaine Laboratories Compliance Gold iFOB (immunological fecal occult blood)Test   K063693 Fecal Occult Blood General Chemistry 07/01/2008 IDEAL LIFE Gluco-Manager GMM 0001 Blood Glucose Monitoring System   K080283 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008 Tyson Bioresearch Inc. Diachex Basic Blood Glucose Monitoring System   K072854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008 Tyson Bioresearch Inc. 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GlucoSure Voice Blood Glucose Monitoring System   K073137 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/18/2008 LifeScan One Touch UltraLink Blood Glucose Monitoring System   K073231 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/18/2008 Neuero Engineering Inc. 3test Supreme Glucose Monitoring System   K072905 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/18/2008 Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) K023639 Triglyceride General Chemistry 04/14/2008 Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) K023640 HDL Cholesterol General Chemistry 04/14/2008 Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) K023642 Cholesterol General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) K023642 Cholesterol General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood) K023642 Cholesterol General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) 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 Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) K942782 Glucose General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) K942782 Albumin General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) K942782 Protein, Total General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) K942782 Bilirubin, Total General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagenr Disc} (Whole Blood) K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) K950164 Alkaline Phosphatase (ALP) General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) K950164 Amylase General Chemistry 04/14/2008 Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood) K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 04/14/2008 Apex Biotechnology Corp. GlucoSure Star Blood Glucose Monitoring System   K073648 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/14/2008 Tyson Bioresearch Inc. Diachex+ Determine Blood Glucose Monitoring System   K073492 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/14/2008 Tyson Bioresearch, Inc., Diachex+ Infinity Blood Glucose Monitoring System   K073492 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/14/2008 Diagnostic Test Group Clarity Strep A Rapid Test Strips   K983386 Streptococcus, Group A Bacteriology 04/08/2008 Bayer A1CNow +  (For professional use) K051321 Glycated Hemoglobin, Total General Chemistry 03/31/2008 Fora Care Inc. 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FastChek TSH  (Whole Blood) K990658 Thyroid Stimulating Hormone (TSH) Endocrinology 02/29/2008 Nova Biomedical Corp. StatStrip Glucose Hospital Meter   K060345 Glucose Monitoring Devices (Prescription Use Only) General Chemistry 02/28/2008 Nova Biomedical, Nova Max Link Blood Glucose Monitoring System   K040603 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/28/2008 Henry Schein One Step + Mononucleosis Rapid Test Device  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/26/2008 Quidel QuickVue RSV Test   K061008 Respiratory Syncytial Virus Virology 02/25/2008 Quidel QuickVue RSV Test   K070747 Respiratory Syncytial Virus Virology 02/25/2008 Clarity MONO Mononucleosis Rapid Test  (Whole Blood) K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/13/2008 AgaMatrix WaveSense KeyNote Codeless Blood Glucose Monitoring System   K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/31/2008 BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)   K063545 Amphetamines Toxicology / TDM 01/30/2008 BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)   K063545 Cannabinoids (THC) Toxicology / TDM 01/30/2008 BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)   K063545 Phencyclidine (PCP) Toxicology / TDM 01/30/2008 BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)   K063545 Cocaine Metabolites Toxicology / TDM 01/30/2008 BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)   K063545 Methadone Toxicology / TDM 01/30/2008 BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)   K063545 Methamphetamines Toxicology / TDM 01/30/2008 BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)   K063545 Benzodiazepines Toxicology / TDM 01/30/2008 BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)   K063545 Barbiturates Toxicology / TDM 01/30/2008 BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)   K063545 Morphine Toxicology / TDM 01/30/2008 BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)   K063545 Tricyclic Antidepressants Toxicology / TDM 01/30/2008 BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)   K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/30/2008 BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)   K063545 Amphetamines Toxicology / TDM 01/30/2008 BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)   K063545 Cannabinoids (THC) Toxicology / TDM 01/30/2008 BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)   K063545 Phencyclidine (PCP) Toxicology / TDM 01/30/2008 BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)   K063545 Cocaine Metabolites Toxicology / TDM 01/30/2008 BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)   K063545 Methadone Toxicology / TDM 01/30/2008 BTNX Inc. 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Rapid Response Multi-Drug One Step Screen Test Panel (Urine)   K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/30/2008 JANT Pharmacal Corporation Accutest Value + Urine Pregnancy Test Device   K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 01/30/2008 Phamatech At Home 12 Drug Test (Model 9308T)   K070009 Amphetamines Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308T)   K070009 Cannabinoids (THC) Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308T)   K070009 Phencyclidine (PCP) Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308T)   K070009 Cocaine Metabolites Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308T)   K070009 Benzodiazepines Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308T)   K070009 Barbiturates Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308T)    K070009 Opiates Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308T)    K070009 Methadone Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308T)    K070009 Methamphetamines Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308T)    K070009 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308Z)   K070009 Amphetamines Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308Z)   K070009 Cannabinoids (THC) Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308Z)   K070009 Phencyclidine (PCP) Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308Z)   K070009 Cocaine Metabolites Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308Z)   K070009 Opiates Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308Z)   K070009 Methadone Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308Z)   K070009 Methamphetamines Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308Z)   K070009 Benzodiazepines Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308Z)   K070009 Barbiturates Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308Z)   K070009 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 9308Z)   K070009 Oxycodone Toxicology / TDM 01/23/2008 Phamatech At Home 12 Drug Test (Model 930T)    K070009 Oxycodone Toxicology / TDM 01/23/2008 Becton Dickinson BD Chek Group A Strep Test   K010582 Streptococcus, Group A Bacteriology 01/22/2008 Diagnostic Test Group Clarity H. pylori Rapid Test Device  (Whole Blood) K980798 Helicobacter Pylori Antibodies General Immunology 01/22/2008 BTNX Inc. Rapid Response H. pylori Whole Blood Rapid Test Device   K024360 Helicobacter Pylori Antibodies General Immunology 01/15/2008 Abbott Diagnostics Signify ER Drug Screen Test    K041685 Amphetamines Toxicology / TDM 01/08/2008 Abbott Diagnostics Signify ER Drug Screen Test    K041685 Cannabinoids (THC) Toxicology / TDM 01/08/2008 Abbott Diagnostics Signify ER Drug Screen Test    K041685 Phencyclidine (PCP) Toxicology / TDM 01/08/2008 Abbott Diagnostics Signify ER Drug Screen Test    K041685 Cocaine Metabolites Toxicology / TDM 01/08/2008 Abbott Diagnostics Signify ER Drug Screen Test    K041685 Opiates Toxicology / TDM 01/08/2008 Abbott Diagnostics Signify ER Drug Screen Test    K041685 Propoxyphene Toxicology / TDM 01/08/2008 Abbott Diagnostics Signify ER Drug Screen Test    K041685 Benzodiazepines Toxicology / TDM 01/08/2008 Abbott Diagnostics Signify ER Drug Screen Test    K041685 Barbiturates Toxicology / TDM 01/08/2008 Abbott Diagnostics Signify ER Drug Screen Test    K041685 Tricyclic Antidepressants Toxicology / TDM 01/08/2008 Abbott Diagnostics Signify ER Drug Screen Test    K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/08/2008 Abbott Diagnostics Signify ER Drug Screen Test    K041685 Oxycodone Toxicology / TDM 01/08/2008 Accutech CholesTrak HDL Cholesterol Home Test   K072836 HDL Cholesterol General Chemistry 01/08/2008 Diagnostic Devices, Inc. Prodigy Autocode Blood Glucose Monitoring System   K072784 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/08/2008 Jant Pharmacal Accutest Value + Mononucleosis Rapid Test  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/08/2008 Stanbio Rely Mono Rapid Test  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/08/2008 TaiDoc Technology Corporation Clever Chek TD-4227 Blood Glucose Monitoring System   K072784 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/08/2008 Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {midstream} (OTC) K071930 hCG, Urine Endocrinology 12/19/2007 Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {cassette} (OTC) K071930 hCG, Urine Endocrinology 12/19/2007 Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {strip} (OTC) K071930 hCG, Urine Endocrinology 12/19/2007 Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {cassette} (Professional Use) K071930 hCG, Urine Endocrinology 12/19/2007 Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {midstream} (professional) K071930 hCG, Urine Endocrinology 12/19/2007 Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {strip} (professional) K071930 hCG, Urine Endocrinology 12/19/2007 Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use) K050878 Amphetamines Toxicology / TDM 12/13/2007 Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use) K050878 Cannabinoids (THC) Toxicology / TDM 12/13/2007 Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use) K050878 Phencyclidine (PCP) Toxicology / TDM 12/13/2007 Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use) K050878 Cocaine Metabolites Toxicology / TDM 12/13/2007 Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use) K050878 Opiates Toxicology / TDM 12/13/2007 Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use) K050878 Methamphetamines Toxicology / TDM 12/13/2007 Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (Professional Use) K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/13/2007 EPS Bio Technology EasyPlus mini Self Monitoring Blood Glucose System   K070053 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/06/2007 Gluco Perfect L.L.C., Gluco Perfect 2 Blood Glucose Monitoring System   K062799 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/06/2007 Jant Pharmacal Accutest Value + H. pylori Rapid Test Device  (Whole Blood) K024350 Helicobacter Pylori Antibodies General Immunology 11/26/2007 Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Ketone Urinalysis 11/16/2007 Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Bilirubin Urinalysis 11/16/2007 Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Glucose Urinalysis 11/16/2007 Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Nitrite Urinalysis 11/16/2007 Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/16/2007 Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Blood Urinalysis 11/16/2007 Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Leukocytes Urinalysis 11/16/2007 Diagnostic Test Group Clarity 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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 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 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Multi-Drug of Abuse Urine Test   K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/28/2007 Arkray, PocketChem EZ Blood Glucose Monitoring System   K063068 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/28/2007 Cardinal Health SP Brand Rapid Test hCG Cassette   K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 06/28/2007 Cardinal Health SP Brand Rapid Test hCG Combo Cassette   K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 06/28/2007 Cardinal Health SP Brand Rapid Test hCG Dipstick   K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 06/28/2007 eScreen, Inc. mCheck Multi-Line Screen Test Device   K050050 Amphetamines Toxicology / TDM 06/28/2007 eScreen, Inc. mCheck Multi-Line Screen Test Device   K050050 Cannabinoids (THC) Toxicology / TDM 06/28/2007 eScreen, Inc. mCheck Multi-Line Screen Test Device   K050050 Phencyclidine (PCP) Toxicology / TDM 06/28/2007 eScreen, Inc. mCheck Multi-Line Screen Test Device   K050050 Cocaine Metabolites Toxicology / TDM 06/28/2007 eScreen, Inc. mCheck Multi-Line Screen Test Device   K050050 Opiates Toxicology / TDM 06/28/2007 eScreen, Inc. mCheck Multi-Line Screen Test Device   K050050 Methamphetamines Toxicology / TDM 06/28/2007 Physicians Medical Supply Quick Chek Blood Glucose Monitoring System   K063212 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/28/2007 PSS World Medical Select Diagnostics Strep A Twist   K023766 Streptococcus, Group A Bacteriology 06/28/2007 Tyson Bioresearch, Inc. EZ Smart-608 Blood Glucose Monitoring System   K062829 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/28/2007 Cambridge Sensors ltd. microdot Blood Glucose Monitoring System   K070524 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/25/2007 Kurkel Enterprises Early-Pregnancy-Tests.com Ovulation Midstream Tests   X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 06/25/2007 Kurkel Enterprises Early-Pregnancy-Tests.com Ovulation Test Strips   X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 06/25/2007 PSS World Medical Select Diagnostics Strep A Dipstick   K010582 Streptococcus, Group A Bacteriology 06/25/2007 Rush Industries Ovulation Test   X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 06/25/2007 Select Medical Products Brand Rapid Test H. Pylori {Whole Blood Only} (H. Pylori) K024350 Helicobacter Pylori Antibodies General Immunology 06/25/2007 Fertell Male Fertility Test    K041039 Semen Hematology 06/18/2007 Nova Biomedical Nova Max Blood Glucose Monitoring System   K070255 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/18/2007 Fisher Healthcare Sure-Vue H. pylori Test  (Whole Blood) K024350 Helicobacter Pylori Antibodies General Immunology 06/11/2007 Inverness Medical Profesional Diagnostics Signify H. pylori Test  (Whole Blood) K024350 Helicobacter Pylori Antibodies General Immunology 06/11/2007 McKesson Medi-Lab Performance H. pylori Test  (Whole Blood) K024350 Helicobacter Pylori Antibodies General Immunology 06/11/2007 Savyon Diagnostics Uriscreen {Bacteriuria}  K882211 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 06/11/2007 PSS World Medical Select hCG Cassette   K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 06/01/2007 PSS World Medical Select hCG Combo   K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 06/01/2007 PSS World Medical Select hCG Dipstick   K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 06/01/2007 Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood) K050652 Creatinine General Chemistry 05/31/2007 Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood) K053401 Protein, Total General Chemistry 05/31/2007 Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood) K053401 Albumin General Chemistry 05/31/2007 Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood) K053401 Calcium, Total General Chemistry 05/31/2007 Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood) K053401 Glucose General Chemistry 05/31/2007 Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood) K053401 Creatinine General Chemistry 05/31/2007 Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 1} (Whole Blood) K053401 Urea (BUN) General Chemistry 05/31/2007 Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood) K053401 Protein, Total General Chemistry 05/31/2007 Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood) K053401 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 05/31/2007 Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood) K053401 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 05/31/2007 Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood) K053401 Alkaline Phosphatase (ALP) General Chemistry 05/31/2007 Arkray SPOTCHEM EZ Chemistry Analyzer {Spotchem II Basicpanel 2} (Whole Blood) K053401 Bilirubin, Total General Chemistry 05/31/2007 Cardinal Health, SP Brand Rapid Test Mono  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 05/31/2007 Roche Diagnostics Corp. ACCU-CHEK Performa System   K070585 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/31/2007 SA Scientific SAS Pregnancy Serum/Urine Test   K010593 Urine hCG By Visual Color Comparison Tests Endocrinology 05/31/2007 Cardinal Health SP Brand Rapid Test H. Pylori {H. Pylori} (Whole Blood) K024350 Helicobacter Pylori Antibodies General Immunology 05/24/2007 Cardinal Health SP Brand Rapid Test Strep A Dipstick   K010582 Streptococcus, Group A Bacteriology 05/24/2007 Innovacon Multi-Clin Drug Screen Test Device   K041685 Amphetamines Toxicology / TDM 05/24/2007 Innovacon Multi-Clin Drug Screen Test Device   K041685 Cannabinoids (THC) Toxicology / TDM 05/24/2007 Innovacon Multi-Clin Drug Screen Test Device   K041685 Phencyclidine (PCP) Toxicology / TDM 05/24/2007 Innovacon Multi-Clin Drug Screen Test Device   K041685 Cocaine Metabolites Toxicology / TDM 05/24/2007 Innovacon Multi-Clin Drug Screen Test Device   K041685 Opiates Toxicology / TDM 05/24/2007 Innovacon Multi-Clin Drug Screen Test Device   K041685 Propoxyphene Toxicology / TDM 05/24/2007 Innovacon Multi-Clin Drug Screen Test Device   K041685 Benzodiazepines Toxicology / TDM 05/24/2007 Innovacon Multi-Clin Drug Screen Test Device   K041685 Barbiturates Toxicology / TDM 05/24/2007 Innovacon Multi-Clin Drug Screen Test Device   K041685 Tricyclic Antidepressants Toxicology / TDM 05/24/2007 Innovacon Multi-Clin Drug Screen Test Device   K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/24/2007 Innovacon Multi-Clin Drug Screen Test Device   K041685 Oxycodone Toxicology / TDM 05/24/2007 Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device   K041685 Amphetamines Toxicology / TDM 05/24/2007 Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device   K041685 Cannabinoids (THC) Toxicology / TDM 05/24/2007 Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device   K041685 Phencyclidine (PCP) Toxicology / TDM 05/24/2007 Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device   K041685 Cocaine Metabolites Toxicology / TDM 05/24/2007 Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device   K041685 Opiates Toxicology / TDM 05/24/2007 Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device   K041685 Propoxyphene Toxicology / TDM 05/24/2007 Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device   K041685 Benzodiazepines Toxicology / TDM 05/24/2007 Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device   K041685 Barbiturates Toxicology / TDM 05/24/2007 Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device   K041685 Tricyclic Antidepressants Toxicology / TDM 05/24/2007 Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device   K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/24/2007 Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device   K041685 Oxycodone Toxicology / TDM 05/24/2007 Immuno Detector Mono {Whole Blood}  K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 05/17/2007 Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood) K922612 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 05/16/2007 Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood) K922612 Triglyceride General Chemistry 05/16/2007 Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood) K922612 HDL Cholesterol General Chemistry 05/16/2007 Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood) K922612 Cholesterol General Chemistry 05/16/2007 Forsure One Step Fecal Occult Blood (FOB) Screen Card Test   K063693 Fecal Occult Blood General Chemistry 05/16/2007 Immunostics Detector H. pylori WB {H. pylori Antiboby Test} (For whole blood) K980798 Helicobacter Pylori Antibodies General Immunology 05/16/2007 KoreaMedico Chextic   K062096 Urine hCG By Visual Color Comparison Tests Endocrinology 05/10/2007 McKesson Medi-Lab Performance Strep A Test - Twist   K023766 Streptococcus, Group A Bacteriology 05/10/2007 PerMaxim RediScreen Strep A Twist Cassette   K023766 Streptococcus, Group A Bacteriology 05/10/2007 AmeriTek USA, dBest One Step hCG Panel Test Kit   K061257 Urine hCG By Visual Color Comparison Tests Endocrinology 05/07/2007 Church & Dwight Co., Inc. FIRST RESPONSE Gold Digital Pregnancy Test   K070054 Urine hCG By Visual Color Comparison Tests Endocrinology 05/07/2007 Diacare Corp. EASY CHECK Blood Glucose Monitoring System   K062538 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/02/2007 Taidoc Technology easi check precise Blood Glucose Monitoring System   K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/02/2007 Abbott Diabetes Care Inc., FreeStyle Lite Glucose Monitoring System   K070850 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/12/2007 BTNX Inc. Rapid Response Blood Glucose Monitoring System   K051854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/12/2007 Clearview MONO Whole Blood  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 04/12/2007 Diabetic Supply of Suncoast, Inc. Advocate Duo Blood Glucose Plus Blood Pressure Monitoring System   K070641 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/12/2007 HemoCue Hb 301 System   K061047 Hemoglobin Hematology 04/12/2007 Medi-Lab Performance Infectious Mononucleosis Test  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 04/12/2007 Signify Mono Whole Blood  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 04/12/2007 Fisher HealthCare Sure-Vue Serum/Urine hCG-STAT   K062361 hCG, Urine Endocrinology 04/02/2007 Jant Pharmacal Corporation Accutest TSH  (Whole Blood) K990658 Thyroid Stimulating Hormone (TSH) Endocrinology 04/02/2007 Bionime Corporation Rightest Blood Glucose Monitoring System   K062567 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/29/2007 Fisher HealthCare Sure-Vue Urine hCG   K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 03/29/2007 Redwood Toxicology Laboratory Reditest Home Drug Test   K050878 Amphetamines Toxicology / TDM 03/29/2007 Redwood Toxicology Laboratory Reditest Home Drug Test   K050878 Cannabinoids (THC) Toxicology / TDM 03/29/2007 Redwood Toxicology Laboratory Reditest Home Drug Test   K050878 Phencyclidine (PCP) Toxicology / TDM 03/29/2007 Redwood Toxicology Laboratory Reditest Home Drug Test   K050878 Cocaine Metabolites Toxicology / TDM 03/29/2007 Redwood Toxicology Laboratory Reditest Home Drug Test   K050878 Opiates Toxicology / TDM 03/29/2007 Redwood Toxicology Laboratory Reditest Home Drug Test   K050878 Methamphetamines Toxicology / TDM 03/29/2007 Redwood Toxicology Laboratory Reditest Home Drug Test   K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/29/2007 Fisher HealthCare Sure-Vue Serum/Urine hCG   K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 03/28/2007 Fisher HealthCare Sure-Vue Strep A Test   K010582 Streptococcus, Group A Bacteriology 03/28/2007 Home Diagnostics, TRUEread Blood Glucose Monitoring System   K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/28/2007 Mckesson Medi-Lab Strep A Test - Dipstick   K010582 Streptococcus, Group A Bacteriology 03/28/2007 McKesson Medical-Surgical Medi-Lab Performance hCG Combo Test-Cassette   K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 03/28/2007 SA Scientific SAS Pregnancy Urine Test   K010522 Urine hCG By Visual Color Comparison Tests Endocrinology 03/28/2007 Roche Diagnostics CoaguChek XS    K060978 Prothrombin Time (PT) Hematology 03/23/2007 Kurkel Enterprises Early-Pregnancy-Tests.com Pregnancy Midstream Tests   K974059 Urine hCG By Visual Color Comparison Tests Endocrinology 03/19/2007 Kurkel Enterprises Early-Pregnancy-Tests.com Pregnancy Test Strips   K951705 Urine hCG By Visual Color Comparison Tests Endocrinology 03/19/2007 Rush Industries Rush Pregnancy Test   K974059 Urine hCG By Visual Color Comparison Tests Endocrinology 03/19/2007 TaiDoc Clever Chek Blood Glucose Monitoring System TD-4230   K070472 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/19/2007 TaiDoc SureChek Blood Glucose Monitoring System   K070472 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/19/2007 Bayer Clinitek Status Urine Chemistry Analyzer   K032563 hCG, Urine Endocrinology 03/16/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K950164 Calcium, Total General Chemistry 03/14/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K934592 Uric Acid General Chemistry 03/14/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Albumin General Chemistry 03/14/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Protein, Total General Chemistry 03/14/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 03/14/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Glucose General Chemistry 03/14/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Creatinine General Chemistry 03/14/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Urea (BUN) General Chemistry 03/14/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Bilirubin, Total General Chemistry 03/14/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 03/14/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) K942782 Glucose General Chemistry 03/14/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) K942782 Creatinine General Chemistry 03/14/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) K942782 Urea (BUN) General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) K942782 Glucose General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) K942782 Creatinine General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) K942782 Urea (BUN) General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Albumin General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Protein, Total General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Glucose General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Creatinine General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Urea (BUN) General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K942782 Bilirubin, Total General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K934592 Uric Acid General Chemistry 03/14/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K950164 Calcium, Total General Chemistry 03/14/2007 Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (Professional Use) K050050 Amphetamines Toxicology / TDM 03/14/2007 Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (Professional Use) K050050 Cannabinoids (THC) Toxicology / TDM 03/14/2007 Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (Professional Use) K050050 Phencyclidine (PCP) Toxicology / TDM 03/14/2007 Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (Professional Use) K050050 Cocaine Metabolites Toxicology / TDM 03/14/2007 Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (Professional Use) K050050 Opiates Toxicology / TDM 03/14/2007 Redwood Toxicology Laboratory Reditest 6 Cassette substance abuse screening device  (Professional Use) K050050 Methamphetamines Toxicology / TDM 03/14/2007 SA Scientific SAS Pregnancy Serum/Urine Test   K010593 Urine hCG By Visual Color Comparison Tests Endocrinology 03/14/2007 Fisher HealthCare Sure-Vue Urine hCG Strip   K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 03/07/2007 Innovacon FOB Flipcard Fecal Occult Blood Test   K063673 Fecal Occult Blood General Chemistry 03/07/2007 McKesson Medical-Surgical, Medi-Lab Performance hCG Urine Test - Cassette   K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 03/07/2007 McKesson Medical-Surgical, Medi-Lab Performance hCG Urine Test - Dipstick   K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 03/07/2007 Tyson Bioresearch, Inc. SMARTCHEX Blood Glucose Monitoring System   K052818 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/07/2007 Roche Diagnostics Accu-Chek Inform System  (Professional Use) K003846 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/26/2007 Roche Diagnostics CoaguChek XS PST   K062925 Prothrombin Time (PT) Hematology 02/26/2007 Apex Biotechnology Corp. Assure 4 Blood Glucose Monitoring System   K070088 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/22/2007 Innovacon Integrated E-Z Split Key Cup II  (Professional Use) K050878 Amphetamines Toxicology / TDM 02/22/2007 Innovacon Integrated E-Z Split Key Cup II   (Professional Use) K050878 Cannabinoids (THC) Toxicology / TDM 02/22/2007 Innovacon Integrated E-Z Split Key Cup II   (Professional Use) K050878 Phencyclidine (PCP) Toxicology / TDM 02/22/2007 Innovacon Integrated E-Z Split Key Cup II   (Professional Use) K050878 Cocaine Metabolites Toxicology / TDM 02/22/2007 Innovacon Integrated E-Z Split Key Cup II   (Professional Use) K050878 Opiates Toxicology / TDM 02/22/2007 Innovacon Integrated E-Z Split Key Cup II   (Professional Use) K050878 Methamphetamines Toxicology / TDM 02/22/2007 Innovacon Integrated E-Z Split Key Cup II   (Professional Use) K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/22/2007 Inverness Medical Professional Devices Clearview hCG Urine Cassette   K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007 Inverness Medical Professional Diagnostics Clearview hCG Combo II   K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007 Inverness Medical Professional Diagnostics Clearview hCG Urine Dipstick   K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007 Inverness Medical Professional Diagnostics Signify hCG Combo Urine/Serum   K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007 Inverness Medical Professional Diagnostics Signify hCG Urine Cassette   K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007 Inverness Medical Professional Diagnostics Signify hCG Urine Dipstick   K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007 Ok Biotech Co., Ltd. Ok Meter Blood Glucose Monitoring System   K063026 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/13/2007 Inverness Medical Clearview Strep A Exact II Dipstick   K010582 Streptococcus, Group A Bacteriology 02/08/2007 Select Diagnostics Immunochemical Fecal Occult Blood Test   K060463 Fecal Occult Blood General Chemistry 02/08/2007 Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis   K023885 Urine Qualitative Dipstick Ketone Urinalysis 02/07/2007 Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis   K023885 Urine Qualitative Dipstick Bilirubin Urinalysis 02/07/2007 Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis   K023885 Urine Qualitative Dipstick Blood Urinalysis 02/07/2007 Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis   K023885 Urine Qualitative Dipstick Glucose Urinalysis 02/07/2007 Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis   K023885 Urine Qualitative Dipstick Leukocytes Urinalysis 02/07/2007 Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis   K023885 Urine Qualitative Dipstick Nitrite Urinalysis 02/07/2007 Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis   K023885 Urine Qualitative Dipstick pH Urinalysis 02/07/2007 Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis   K023885 Urine Qualitative Dipstick Protein Urinalysis 02/07/2007 Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis   K023885 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/07/2007 Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis   K023885 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/07/2007 Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis   K023885 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 02/07/2007 Inverness Medical Clearview H. pylori Test  (Whole Blood) K024350 Helicobacter Pylori Antibodies General Immunology 02/07/2007 Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}  K070017 Triglyceride General Chemistry 02/07/2007 Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}  K070017 HDL Cholesterol General Chemistry 02/07/2007 Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}  K070017 Glucose General Chemistry 02/07/2007 Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}  K070017 Triglyceride General Chemistry 02/07/2007 Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}  K070017 HDL Cholesterol General Chemistry 02/07/2007 Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}  K070017 Glucose General Chemistry 02/07/2007 Apex Biotechnology Corp. Gluco Track Blood Glucose Monitoring System   K062799 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/05/2007 TaiDoc Advocate Blood Glucose Monitoring System   K063212 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/31/2007 Teco Diagnostics Microalbumin 2-1 Combo Strip   K061419 Urine Qualitative Dipstick Protein Urinalysis 01/29/2007 Teco Diagnostics Microalbumin 2-1 Combo Strip   K061419 Urine Qualitative Dipstick Creatinine Urinalysis 01/29/2007 EUKARE Blood Glucose Monitoring System   K062892 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/26/2007 InSure Quik Fecal Immunochemical Test (F.I.T.)   K060930 Fecal Occult Blood General Chemistry 01/26/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 01/22/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K950164 Alkaline Phosphatase (ALP) General Chemistry 01/22/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K950164 Amylase General Chemistry 01/22/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 01/22/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 01/22/2007 Abaxis Piccolo Blood Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 01/22/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 01/22/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 01/22/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 01/22/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 6 Panel} (Whole Blood) K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 01/22/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K950164 Alkaline Phosphatase (ALP) General Chemistry 01/22/2007 Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood) K950164 Amylase General Chemistry 01/22/2007 Abaxis, Piccolo xpress Chemistry Analyzer   K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 01/22/2007 Abaxis, Piccolo xpress Chemistry Analyzer   K950164 Alkaline Phosphatase (ALP) General Chemistry 01/22/2007 Abaxis, Piccolo xpress Chemistry Analyzer   K950164 Amylase General Chemistry 01/22/2007 Abaxis, Piccolo xpress Chemistry Analyzer   K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 01/22/2007 Abaxis, Piccolo xpress Chemistry Analyzer   K942782 Albumin General Chemistry 01/22/2007 Abaxis, Piccolo xpress Chemistry Analyzer   K942782 Protein, Total General Chemistry 01/22/2007 Abaxis, Piccolo xpress Chemistry Analyzer   K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 01/22/2007 Abaxis, Piccolo xpress Chemistry Analyzer   K942782 Glucose General Chemistry 01/22/2007 Abaxis, Piccolo xpress Chemistry Analyzer   K942782 Bilirubin, Total General Chemistry 01/22/2007 Abaxis, Piccolo xpress Chemistry Analyzer   K023639 Triglyceride General Chemistry 01/22/2007 Abaxis, Piccolo xpress Chemistry Analyzer   K023640 HDL Cholesterol General Chemistry 01/22/2007 Abaxis, Piccolo xpress Chemistry Analyzer   K023642 Cholesterol General Chemistry 01/22/2007 Taidoc Technology Corporation Clever Chek TD-3213 Blood Glucose Plus Blood Pressure Monitoring System   K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007 Taidoc Technology Corporation Clever Chek TD-3215 Blood Glucose Plus Blood Pressure Monitoring System   K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007 Taidoc Technology Corporation Clever Chek TD-3217 Blood Glucose Plus Blood Pressure Monitoring System   K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007 Taidoc Technology Corporation Clever Chek TD-3250 Blood Glucose Plus Blood Pressure Monitoring System   K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007 Taidoc Technology Corporation Dr. T TD-3216 Blood Glucose Plus Blood Pressure Monitoring System    K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007 US Diagnostics, Inc. EASYGLUCO Glucose Monitoring System   K061431 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/18/2007 Natureplex, LLC BE CERTAIN Home Pregnancy Test   K051963 Urine hCG By Visual Color Comparison Tests Endocrinology 01/12/2007 Arkray, Ferrara Blood Glucose Monitoring System   K063068 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/09/2007 Common Sense Ltd. Fem-V Test Kit   K043109 Vaginal pH General Chemistry 01/09/2007 Henry Schein Urispec 4-Way Reagent Test Strips   K991927 Urine Qualitative Dipstick Glucose Urinalysis 01/09/2007 Henry Schein Urispec 4-Way Reagent Test Strips   K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 01/09/2007 Henry Schein Urispec 4-Way Reagent Test Strips   K991927 Urine Qualitative Dipstick Nitrite Urinalysis 01/09/2007 Henry Schein Urispec 4-Way Reagent Test Strips   K991927 Urine Qualitative Dipstick Protein Urinalysis 01/09/2007 LifeSign, LLC Status hCG Strip   K950307 Urine hCG By Visual Color Comparison Tests Endocrinology 01/09/2007 ARJ Medical URITEST 10 Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Ketone Urinalysis 12/30/2006 ARJ Medical URITEST 10 Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Bilirubin Urinalysis 12/30/2006 ARJ Medical URITEST 10 Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Blood Urinalysis 12/30/2006 ARJ Medical URITEST 10 Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Glucose Urinalysis 12/30/2006 ARJ Medical URITEST 10 Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Leukocytes Urinalysis 12/30/2006 ARJ Medical URITEST 10 Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Nitrite Urinalysis 12/30/2006 ARJ Medical URITEST 10 Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick pH Urinalysis 12/30/2006 ARJ Medical URITEST 10 Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Protein Urinalysis 12/30/2006 ARJ Medical URITEST 10 Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Urobilinogen Urinalysis 12/30/2006 ARJ Medical URITEST 10 Reagent Strips for Urinalysis   K052719 Urine Qualitative Dipstick Specific Gravity Urinalysis 12/30/2006 Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup   K050878 Amphetamines Toxicology / TDM 12/28/2006 Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup   K050878 Cannabinoids (THC) Toxicology / TDM 12/28/2006 Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup   K050878 Phencyclidine (PCP) Toxicology / TDM 12/28/2006 Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup   K050878 Cocaine Metabolites Toxicology / TDM 12/28/2006 Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup   K050878 Opiates Toxicology / TDM 12/28/2006 Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup   K050878 Methamphetamines Toxicology / TDM 12/28/2006 Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup   K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/28/2006 Wolfe Drug Testing RealityCheck Integrated Specimen Cup   K050878 Amphetamines Toxicology / TDM 12/28/2006 Wolfe Drug Testing RealityCheck Integrated Specimen Cup   K050878 Cannabinoids (THC) Toxicology / TDM 12/28/2006 Wolfe Drug Testing RealityCheck Integrated Specimen Cup   K050878 Phencyclidine (PCP) Toxicology / TDM 12/28/2006 Wolfe Drug Testing RealityCheck Integrated Specimen Cup   K050878 Cocaine Metabolites Toxicology / TDM 12/28/2006 Wolfe Drug Testing RealityCheck Integrated Specimen Cup   K050878 Opiates Toxicology / TDM 12/28/2006 Wolfe Drug Testing RealityCheck Integrated Specimen Cup   K050878 Methamphetamines Toxicology / TDM 12/28/2006 Wolfe Drug Testing RealityCheck Integrated Specimen Cup   K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/28/2006 Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole Blood) K042443 Triglyceride General Chemistry 12/12/2006 Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole Blood) K042443 HDL Cholesterol General Chemistry 12/12/2006 Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole Blood) K042443 Cholesterol General Chemistry 12/12/2006 Taidoc Clever Chek Blood Glucose Monitoring System TD-4223   K063212 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2006 Taidoc Clever Chek Blood Glucose Monitoring System TD-4231   K063212 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2006 Bayer Diagnostics Ascencia BREEZE 2 Blood Glucose Monitoring System   K062347 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/22/2006 LifeSign Status Mono  (For whole blood) K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 11/22/2006 All Medicus GlucoDr SuperSensor Blood Glucose Test System   K050985 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/20/2006 Chembio HIV 1/2 STAT-PAK Assay  (Fingerstick, Venipuncture Whole Blood) BP050010 HIV Antibodies General Immunology 11/20/2006 Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K023489 Amphetamines Toxicology / TDM 11/14/2006 Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K023489 Cannabinoids (THC) Toxicology / TDM 11/14/2006 Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K023489 Phencyclidine (PCP) Toxicology / TDM 11/14/2006 Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K023489 Cocaine Metabolites Toxicology / TDM 11/14/2006 Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K023489 Opiates Toxicology / TDM 11/14/2006 Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K023489 Methadone Toxicology / TDM 11/14/2006 Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K023489 Methamphetamines Toxicology / TDM 11/14/2006 Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K023489 Benzodiazepines Toxicology / TDM 11/14/2006 Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K023489 Barbiturates Toxicology / TDM 11/14/2006 Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K023489 Tricyclic Antidepressants Toxicology / TDM 11/14/2006 Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K023489 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/14/2006 Branan Medical Corporation, FasTox Multiple Drug Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K023489 Oxycodone Toxicology / TDM 11/14/2006 Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K022355 Amphetamines Toxicology / TDM 11/14/2006 Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K022355 Cannabinoids (THC) Toxicology / TDM 11/14/2006 Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K022355 Phencyclidine (PCP) Toxicology / TDM 11/14/2006 Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K022355 Cocaine Metabolites Toxicology / TDM 11/14/2006 Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K022355 Opiates Toxicology / TDM 11/14/2006 Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K022355 Methadone Toxicology / TDM 11/14/2006 Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K022355 Methamphetamines Toxicology / TDM 11/14/2006 Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K022355 Benzodiazepines Toxicology / TDM 11/14/2006 Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K022355 Barbiturates Toxicology / TDM 11/14/2006 Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K022355 Tricyclic Antidepressants Toxicology / TDM 11/14/2006 Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K022355 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/14/2006 Branan Medical Corporation, QuickToxDrug Screen Dipcard (AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/PCP/TCA/THC)   K022355 Oxycodone Toxicology / TDM 11/14/2006 Inverness Medical - BioStar Inc. Acceava hCG Basic II   K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 11/14/2006 Planned Parenthood hCG Pregnancy Test Dipstick   K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 11/14/2006 Planned Parenthood hCG Pregnancy Test One Step Cassette   K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 11/14/2006 Bayer Clinitek Status Urine Chemistry Analyzer   K031947 Microalbumin General Chemistry 11/01/2006 BioStar Acceava Mono II  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 11/01/2006 BTNX Inc Rapid Response H. pylori Rapid Test Device  (Whole Blood) K024350 Helicobacter Pylori Antibodies General Immunology 11/01/2006 GlucoPlus Inc. GlucoPlus Blood Glucose Monitoring System   K061234 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/01/2006 Innovacon hCG Ultra Test Device   K062361 hCG, Urine Endocrinology 11/01/2006 Inverness Medical BioStar Acceava Strep A Test   K010582 Streptococcus, Group A Bacteriology 11/01/2006 BTNX Inc. Rapid Response 11 Parameters Ultra   K023885 Urine Qualitative Dipstick Ketone Urinalysis 10/27/2006 BTNX Inc. Rapid Response 11 Parameters Ultra   K023885 Urine Qualitative Dipstick Bilirubin Urinalysis 10/27/2006 BTNX Inc. Rapid Response 11 Parameters Ultra   K023885 Urine Qualitative Dipstick Blood Urinalysis 10/27/2006 BTNX Inc. Rapid Response 11 Parameters Ultra   K023885 Urine Qualitative Dipstick Glucose Urinalysis 10/27/2006 BTNX Inc. Rapid Response 11 Parameters Ultra   K023885 Urine Qualitative Dipstick Leukocytes Urinalysis 10/27/2006 BTNX Inc. Rapid Response 11 Parameters Ultra   K023885 Urine Qualitative Dipstick Nitrite Urinalysis 10/27/2006 BTNX Inc. Rapid Response 11 Parameters Ultra   K023885 Urine Qualitative Dipstick pH Urinalysis 10/27/2006 BTNX Inc. Rapid Response 11 Parameters Ultra   K023885 Urine Qualitative Dipstick Protein Urinalysis 10/27/2006 BTNX Inc. Rapid Response 11 Parameters Ultra   K023885 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/27/2006 BTNX Inc. Rapid Response 11 Parameters Ultra   K023885 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/27/2006 BTNX Inc. Rapid Response 11 Parameters Ultra   K023885 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 10/27/2006 AgaMatrix GRACEpro Blood Glucose Monitoring System   K052762 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/20/2006 AgaMatrix KeyNote Blood Glucose Monitoring System   K052762 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/20/2006 Clarity H. pylori Rapid Test Device  (Whole Blood) K024350 Helicobacter Pylori Antibodies General Immunology 10/20/2006 Tyson Bioresearch Inc. DIACHEX Blood Glucose Monitoring System   K062829 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/20/2006 Genzyme Diagnostics OSOM BVBLUE Test   K050755 Aerobic/Anaerobic Organisms - Vaginal Bacteriology 10/16/2006 HemoCue Hb 301 System   K061047 Hemoglobin Hematology 10/10/2006 Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood) K041427 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 10/05/2006 Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 10/04/2006 Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 10/04/2006 Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) K950164 Alkaline Phosphatase (ALP) General Chemistry 10/04/2006 Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) K950164 Amylase General Chemistry 10/04/2006 Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) K942782 Albumin General Chemistry 10/04/2006 Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) K942782 Protein, Total General Chemistry 10/04/2006 Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 10/04/2006 Abaxis Piccolo Point of Care Chemistry Analyzer {Liver Panel Plus Reagent Disc} (Whole Blood) K942782 Bilirubin, Total General Chemistry 10/04/2006 Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood) K050077 Urea (BUN) General Chemistry 10/04/2006 Biosite Triage Meterpro  (Whole Blood) K021317 B-Type Natriuretic Peptide (BNP) General Chemistry 10/04/2006 Card Guard Scientific Survival Ltd. SelfCheck Gluco Diabetes Blood Glucose Test System   K061528 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/04/2006 Little Nell Labs ThyroChek TSH   (Whole Blood) K990658 Thyroid Stimulating Hormone (TSH) Endocrinology 10/04/2006 i-Sens Inc. CareSense Blood Glucose Monitoring System   K051651 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/02/2006 EPS Bio Technology Easy Plus Blood Glucose Monitoring System   K061992 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/22/2006 OcculTech Fecal Occult Blood Rapid Test   K060953 Fecal Occult Blood General Chemistry 09/22/2006 ESA Biosciences LeadCare II Blood Lead Testing System  (Whole Blood) K052549 Blood Lead Toxicology / TDM 09/18/2006 Runbio Biotech Co., Ltd. David Pregnancy Test (Midstream)   K053236 Urine hCG By Visual Color Comparison Tests Endocrinology 09/05/2006 Runbio Biotech Co., Ltd. David Pregnancy Test (Strip)   K053236 Urine hCG By Visual Color Comparison Tests Endocrinology 09/05/2006 UltraCrit   BK050056 Hematocrit Hematology 08/31/2006 WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup   K050878 Amphetamines Toxicology / TDM 08/21/2006 WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup   K050878 Cannabinoids (THC) Toxicology / TDM 08/21/2006 WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup   K050878 Phencyclidine (PCP) Toxicology / TDM 08/21/2006 WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup   K050878 Cocaine Metabolites Toxicology / TDM 08/21/2006 WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup   K050878 Opiates Toxicology / TDM 08/21/2006 WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup   K050878 Methamphetamine/Amphetamine Toxicology / TDM 08/21/2006 WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup   K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 08/21/2006 ACON Laboratories Inc. Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Ketone Urinalysis 08/14/2006 ACON Laboratories Inc. Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 08/14/2006 ACON Laboratories Inc. Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Blood Urinalysis 08/14/2006 ACON Laboratories Inc. Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Glucose Urinalysis 08/14/2006 ACON Laboratories Inc. Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 08/14/2006 ACON Laboratories Inc. Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Nitrite Urinalysis 08/14/2006 ACON Laboratories Inc. Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick pH Urinalysis 08/14/2006 ACON Laboratories Inc. Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Protein Urinalysis 08/14/2006 ACON Laboratories Inc. Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 08/14/2006 ACON Laboratories Inc. Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 08/14/2006 ACON Laboratories Inc. Urinalysis Reagent Strips   K061559 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 08/14/2006 Teco Rapid Fecal Occult Blood (FOB) Card Test   K061065 Fecal Occult Blood General Chemistry 08/09/2006 Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana (THC)   K040327 Cannabinoids (THC) Toxicology / TDM 08/08/2006 Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana and Cocaine (THC, COC)   K040327 Cannabinoids (THC) Toxicology / TDM 08/08/2006 Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana and Cocaine (THC, COC)   K040327 Cocaine Metabolites Toxicology / TDM 08/08/2006 WayPoint Biomedical Inc. Health Essist Home Drug Test Marijuana and Cocaine   K050936 Cocaine Metabolites Toxicology / TDM 08/08/2006 Waypoint Biomedical, Inc. Health Essist Home Drug Test Marijuana and Cocaine   K050936 Cannabinoids (THC) Toxicology / TDM 08/08/2006 Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL   K970250 Urine Qualitative Dipstick Ketone Urinalysis 08/07/2006 Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL   K970250 Urine Qualitative Dipstick Bilirubin Urinalysis 08/07/2006 Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL   K970250 Urine Qualitative Dipstick Blood Urinalysis 08/07/2006 Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL   K970250 Urine Qualitative Dipstick Glucose Urinalysis 08/07/2006 Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL   K970250 Urine Qualitative Dipstick Leukocytes Urinalysis 08/07/2006 Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL   K970250 Urine Qualitative Dipstick Nitrite Urinalysis 08/07/2006 Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL   K970250 Urine Qualitative Dipstick pH Urinalysis 08/07/2006 Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL   K970250 Urine Qualitative Dipstick Protein Urinalysis 08/07/2006 Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL   K970250 Urine Qualitative Dipstick Urobilinogen Urinalysis 08/07/2006 Biotron Diagnostics Inc. Urofast Urine Reagent Strip 10 SGL   K970250 Urine Qualitative Dipstick Specific Gravity Urinalysis 08/07/2006 ENTERIX INSURE II FECAL IMMUNOCHEMICAL TEST   K060930 Fecal Occult Blood General Chemistry 08/03/2006 Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips   K023885 Urine Qualitative Dipstick Ketone Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips   K023885 Urine Qualitative Dipstick Bilirubin Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips   K023885 Urine Qualitative Dipstick Blood Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips   K023885 Urine Qualitative Dipstick Glucose Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips   K023885 Urine Qualitative Dipstick Leukocytes Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips   K023885 Urine Qualitative Dipstick Nitrite Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips   K023885 Urine Qualitative Dipstick pH Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips   K023885 Urine Qualitative Dipstick Protein Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips   K023885 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips   K023885 Urine Qualitative Dipstick Specific Gravity Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Plus Urine Test Strips   K023885 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Urine Test Strips   K023885 Urine Qualitative Dipstick Ketone Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Urine Test Strips   K023885 Urine Qualitative Dipstick Bilirubin Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Urine Test Strips   K023885 Urine Qualitative Dipstick Blood Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Urine Test Strips   K023885 Urine Qualitative Dipstick Glucose Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Urine Test Strips   K023885 Urine Qualitative Dipstick Leukocytes Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Urine Test Strips   K023885 Urine Qualitative Dipstick Nitrite Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Urine Test Strips   K023885 Urine Qualitative Dipstick pH Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Urine Test Strips   K023885 Urine Qualitative Dipstick Protein Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Urine Test Strips   K023885 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Urine Test Strips   K023885 Urine Qualitative Dipstick Specific Gravity Urinalysis 07/27/2006 Analyticon Biotechnologies AG Combi-Screen Urine Test Strips   K023885 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/27/2006 Diagnostic Devices Prodigy Blood Glucose Test System   K060467 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/27/2006 Home Diagnostics Element Blood Glucose Monitoring System   K060793 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/27/2006 PerMaxim RediScreen Mononucleosis  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 07/27/2006 IRIS vChem 10 SG Urine Chemistry Stips   K861255 Urine Qualitative Dipstick Bilirubin Urinalysis 07/13/2006 IRIS vChem 10 SG Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Ketone Urinalysis 07/13/2006 IRIS vChem 10 SG Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Blood Urinalysis 07/13/2006 IRIS vChem 10 SG Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Glucose Urinalysis 07/13/2006 IRIS vChem 10 SG Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Leukocytes Urinalysis 07/13/2006 IRIS vChem 10 SG Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Nitrite Urinalysis 07/13/2006 IRIS vChem 10 SG Urine Chemistry Strips   K861255 Urine Qualitative Dipstick pH Urinalysis 07/13/2006 IRIS vChem 10 SG Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Protein Urinalysis 07/13/2006 IRIS vChem 10 SG Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/13/2006 IRIS vChem 10 SG Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Specific Gravity Urinalysis 07/13/2006 IRIS vChem 10 SG Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/13/2006 IRIS vChem 2 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Glucose Urinalysis 07/13/2006 IRIS vChem 2 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/13/2006 IRIS vChem 2 Urine Chemstry Strips   K861255 Urine Qualitative Dipstick Protein Urinalysis 07/13/2006 IRIS vChem 6 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Ketone Urinalysis 07/13/2006 IRIS vChem 6 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Blood Urinalysis 07/13/2006 IRIS vChem 6 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Glucose Urinalysis 07/13/2006 IRIS vChem 6 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Leukocytes Urinalysis 07/13/2006 IRIS vChem 6 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick pH Urinalysis 07/13/2006 IRIS vChem 6 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Protein Urinalysis 07/13/2006 IRIS vChem 6 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/13/2006 IRIS vChem 8 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Ketone Urinalysis 07/13/2006 IRIS vChem 8 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Bilirubin Urinalysis 07/13/2006 IRIS vChem 8 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Blood Urinalysis 07/13/2006 IRIS vChem 8 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Glucose Urinalysis 07/13/2006 IRIS vChem 8 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Nitrite Urinalysis 07/13/2006 IRIS vChem 8 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick pH Urinalysis 07/13/2006 IRIS vChem 8 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Protein Urinalysis 07/13/2006 IRIS vChem 8 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/13/2006 IRIS vChem 8 Urine Chemistry Strips   K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/13/2006 Diagnostic Devices, Inc. Prodigy Blood Glucose Monitoring System   K053593 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/07/2006 i-Sense Inc. CareSens Blood Glucose Monitoring System   K051651 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/07/2006 Beckman Coulter ICON HP test  ((for whole blood)) K980798 Helicobacter Pylori Antibodies General Immunology 06/30/2006 Beckman Coulter ICON SC Strep A test   K040708 Streptococcus, Group A Bacteriology 06/30/2006 Gryphus Diagnostics BVBlue   K050755 Aerobic/Anaerobic Organisms - Vaginal Bacteriology 06/30/2006 PFIZER CONSUMER HEALTHCARE e.p.t. Certainty 1-Step Pregnancy Test   K061769 Urine hCG By Visual Color Comparison Tests Endocrinology 06/30/2006 Taidoc Technology easy check TD-4209 Blood Glucose Monitoring System    K042005 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2006 Tyson Bioresearch, Inc. EZ-Smart-168 Blood Glucose Monitoring System   K052818 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2006 Mizuho USA Multi-Use Electronic Pregnancy Test   K060825 Urine hCG By Visual Color Comparison Tests Endocrinology 06/20/2006 Diagnostic Test Group, Clarity Blood Glucose Monitoring System   K051854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/15/2006 HealthPia America Corporation, GlucoPack Blood Glucose Monitoring System   K052469 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/15/2006 Immunostics, Inc., hema-screen SPECIFIC Immunochemical Fecal Occult Blood Test   K060463 Fecal Occult Blood General Chemistry 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine   K040629 Amphetamines Toxicology / TDM 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine   K040629 Cannabinoids (THC) Toxicology / TDM 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine   K040629 Phencyclidine (PCP) Toxicology / TDM 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine   K040629 Cocaine Metabolites Toxicology / TDM 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine   K040629 Opiates Toxicology / TDM 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine   K040629 Methamphetamines Toxicology / TDM 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine   K041221 Amphetamines Toxicology / TDM 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine   K041221 Cannabinoids (THC) Toxicology / TDM 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine   K041221 Phencyclidine (PCP) Toxicology / TDM 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine   K041221 Cocaine Metabolites Toxicology / TDM 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine   K041221 Opiates Toxicology / TDM 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine   K041221 Methamphetamines Toxicology / TDM 06/15/2006 Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine   K041221 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/15/2006 Taidoc Clever Chek TD-3250 Blood Glucose Plus Blood Pressure Monitoring System   K061073 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/06/2006 Inverness Medical, Inc. Clearblue Easy Digital Pregnancy Test   K060128 Urine hCG By Visual Color Comparison Tests Endocrinology 06/01/2006 Kareway Product Pure-Aid Pregnancy Test   K053452 Urine hCG By Visual Color Comparison Tests Endocrinology 05/31/2006 Meridian Bioscience Immunocard STAT! HpSA  (Stool) K032222 Helicobacter Pylori Bacteriology 05/31/2006 BTNX Inc. Rapid Response One Step hCG Pregnancy Urine Test Cassette   K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 05/22/2006 BTNX Inc. Rapid Response One Step hCG Pregnancy Urine Test Strip   K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 05/22/2006 BTNX Inc. Rapid Response One Step hCG Pregnancy Urine/Serum Combo Cassette Test   K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 05/22/2006 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Ketone Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Blood Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Glucose Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Nitrite Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K993850 Urine Qualitative Dipstick pH Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Protein Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 10 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 2 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Glucose Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 2 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Protein Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 4 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Glucose Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 4 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 4 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Nitrite Urinalysis 05/22/2006 Jant Pharmacal Accutest URS 4 Urine Reagent Strips   K993850 Urine Qualitative Dipstick Protein Urinalysis 05/22/2006 LifeScan OneTouch UltraMini Blood Glucose Monitoring System   K061118 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/22/2006 Progressive Health Supply and Source Smartest Protege Blood Glucose Monitoring System   K032029 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/22/2006 CEN-MED Elite Plus hCG One Step Pregnancy Test Device (Urine/Serum)   K981165 Urine hCG By Visual Color Comparison Tests Endocrinology 05/15/2006 Abbott Diabetes Care Inc. Optium Blood Glucose Monitoring System   K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2006 Acon Laboratories Multi-Clin Drug Screen Test Device   K041685 Amphetamines Toxicology / TDM 05/01/2006 Acon Laboratories Multi-Clin Drug Screen Test Device   K041685 Cannabinoids (THC) Toxicology / TDM 05/01/2006 Acon Laboratories Multi-Clin Drug Screen Test Device   K041685 Phencyclidine (PCP) Toxicology / TDM 05/01/2006 Acon Laboratories Multi-Clin Drug Screen Test Device   K041685 Cocaine Metabolites Toxicology / TDM 05/01/2006 Acon Laboratories Multi-Clin Drug Screen Test Device   K041685 Propoxyphene Toxicology / TDM 05/01/2006 Acon Laboratories Multi-Clin Drug Screen Test Device   K041685 Benzodiazepines Toxicology / TDM 05/01/2006 Acon Laboratories Multi-Clin Drug Screen Test Device   K041685 Barbiturates Toxicology / TDM 05/01/2006 Acon Laboratories Multi-Clin Drug Screen Test Device   K041685 Morphine Toxicology / TDM 05/01/2006 Acon Laboratories Multi-Clin Drug Screen Test Device   K041685 Tricyclic Antidepressants Toxicology / TDM 05/01/2006 Acon Laboratories Multi-Clin Drug Screen Test Device   K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/01/2006 Acon Laboratories Multi-Clin Drug Screen Test Device   K041685 Oxycodone Toxicology / TDM 05/01/2006 Acon Laboratories Tri-Fect Drug Screen Test Device   K041743 Amphetamines Toxicology / TDM 05/01/2006 Acon Laboratories Tri-Fect Drug Screen Test Device   K041743 Cannabinoids (THC) Toxicology / TDM 05/01/2006 Acon Laboratories Tri-Fect Drug Screen Test Device   K041743 Phencyclidine (PCP) Toxicology / TDM 05/01/2006 Acon Laboratories Tri-Fect Drug Screen Test Device   K041743 Cocaine Metabolites Toxicology / TDM 05/01/2006 Acon Laboratories Tri-Fect Drug Screen Test Device   K041743 Propoxyphene Toxicology / TDM 05/01/2006 Acon Laboratories Tri-Fect Drug Screen Test Device   K041743 Benzodiazepines Toxicology / TDM 05/01/2006 Acon Laboratories Tri-Fect Drug Screen Test Device   K041743 Barbiturates Toxicology / TDM 05/01/2006 Acon Laboratories Tri-Fect Drug Screen Test Device   K041743 Morphine Toxicology / TDM 05/01/2006 Acon Laboratories Tri-Fect Drug Screen Test Device   K041743 Tricyclic Antidepressants Toxicology / TDM 05/01/2006 Acon Laboratories Tri-Fect Drug Screen Test Device   K041743 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/01/2006 Acon Laboratories Tri-Fect Drug Screen Test Device   K041743 Oxycodone Toxicology / TDM 05/01/2006 First Check Diagnostics LLC, First Check Home Drug Test Marijuana   K050936 Cannabinoids (THC) Toxicology / TDM 05/01/2006 Solartek Products, Inc. Kroger Blood Glucose Monitoring System   K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2006 Solartek Products, Inc. ReliOn Ultima Blood Glucose Monitoring System   K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2006 Solartek Products, Inc. RiteAid Blood Glucose Monitoring System   K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2006 BinaxNOW Influenza A & B Test  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens) K053126 Influenza A/B Virology 04/19/2006 MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)   K993850 Urine Qualitative Dipstick Ketone Urinalysis 04/19/2006 MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)   K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 04/19/2006 MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)   K993850 Urine Qualitative Dipstick Blood Urinalysis 04/19/2006 MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)   K993850 Urine Qualitative Dipstick Glucose Urinalysis 04/19/2006 MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)   K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 04/19/2006 MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)   K993850 Urine Qualitative Dipstick Nitrite Urinalysis 04/19/2006 MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)   K993850 Urine Qualitative Dipstick pH Urinalysis 04/19/2006 MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)   K993850 Urine Qualitative Dipstick Protein Urinalysis 04/19/2006 MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)   K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 04/19/2006 MYM Laboratory & Medical Supply Urinalysis Reagent Strips (10 Parameters)   K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 04/19/2006 Noble Medical Inc. Split-Specimen Cup   K050878 Amphetamines Toxicology / TDM 04/19/2006 Noble Medical Inc. Split-Specimen Cup   K050878 Cannabinoids (THC) Toxicology / TDM 04/19/2006 Noble Medical Inc. Split-Specimen Cup   K050878 Phencyclidine (PCP) Toxicology / TDM 04/19/2006 Noble Medical Inc. Split-Specimen Cup   K050878 Cocaine Metabolites Toxicology / TDM 04/19/2006 Noble Medical Inc. Split-Specimen Cup   K050878 Opiates Toxicology / TDM 04/19/2006 Noble Medical Inc. Split-Specimen Cup   K050878 Methamphetamines Toxicology / TDM 04/19/2006 Noble Medical Inc. Split-Specimen Cup   K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 04/19/2006 US Diagnostics, Inc. G4 Blood Glucose Monitoring System   K051651 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/19/2006 DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   K052525 Urine Qualitative Dipstick Ketone Urinalysis 04/11/2006 DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   K052525 Urine Qualitative Dipstick Bilirubin Urinalysis 04/11/2006 DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   K052525 Urine Qualitative Dipstick Blood Urinalysis 04/11/2006 DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   K052525 Urine Qualitative Dipstick Glucose Urinalysis 04/11/2006 DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   K052525 Urine Qualitative Dipstick Nitrite Urinalysis 04/11/2006 DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   K052525 Urine Qualitative Dipstick pH Urinalysis 04/11/2006 DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   K052525 Urine Qualitative Dipstick Protein Urinalysis 04/11/2006 DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   K052525 Urine Qualitative Dipstick Specific Gravity Urinalysis 04/11/2006 DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   K052525 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 04/11/2006 DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis    K052525 Urine Qualitative Dipstick Leukocytes Urinalysis 04/11/2006 DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis    K052525 Urine Qualitative Dipstick Urobilinogen Urinalysis 04/11/2006 Polymer Technology Systems CardioChek Analyzer {PTS PANELS HDL Cholesterol Test Strips}  K060617 HDL Cholesterol General Chemistry 04/10/2006 Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS HDL Cholesterol Test Strips}  K060617 HDL Cholesterol General Chemistry 04/10/2006 Hypoguard Assure Pro Blood Glucose Monitoring System   K053079 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2006 Rapid Pathogen Screening RPS Adeno Detector   K052092 Adenovirus Virology 03/30/2006 immoCARE Fecal Occult Blood Test   K052598 Fecal Occult Blood General Chemistry 03/22/2006 Abbott Freestyle Feedom Blood Glucose Monitoring System   K051839 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2006 Johnson & Johnson, Lifescan, Inc. One Touch Basic Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip}  K052207 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2006 Johnson & Johnson, Lifescan, Inc. One Touch II Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip}  K052207 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2006 Johnson & Johnson, Lifescan, Inc. One Touch Profile Blood Glucose Meter {Incline Medical, LLC Accurex Glucose Test Strip}  K052207 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2006 MACHEREY-NAGEL Medi-Test Combi 10 SGL   K991927 Urine Qualitative Dipstick Ketone Urinalysis 03/13/2006 MACHEREY-NAGEL Medi-Test Combi 10 SGL   K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 03/13/2006 MACHEREY-NAGEL Medi-Test Combi 10 SGL   K991927 Urine Qualitative Dipstick Blood Urinalysis 03/13/2006 MACHEREY-NAGEL Medi-Test Combi 10 SGL   K991927 Urine Qualitative Dipstick Glucose Urinalysis 03/13/2006 MACHEREY-NAGEL Medi-Test Combi 10 SGL   K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 03/13/2006 MACHEREY-NAGEL Medi-Test Combi 10 SGL   K991927 Urine Qualitative Dipstick Nitrite Urinalysis 03/13/2006 MACHEREY-NAGEL Medi-Test Combi 10 SGL   K991927 Urine Qualitative Dipstick pH Urinalysis 03/13/2006 MACHEREY-NAGEL Medi-Test Combi 10 SGL   K991927 Urine Qualitative Dipstick Protein Urinalysis 03/13/2006 MACHEREY-NAGEL Medi-Test Combi 10 SGL   K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 03/13/2006 MACHEREY-NAGEL Medi-Test Combi 10 SGL   K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 03/13/2006 Bioptik Technology, Inc. EasyMate Blood Glucose Monitoring System   K053312 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/09/2006 Ani Biotech Oy MySet Pregnancy Test   K053138 hCG, Urine Endocrinology 03/03/2006 Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device   K050050 Amphetamines Toxicology / TDM 03/03/2006 Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device   K050050 Cannabinoids (THC) Toxicology / TDM 03/03/2006 Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device   K050050 Phencyclidine (PCP) Toxicology / TDM 03/03/2006 Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device   K050050 Cocaine Metabolites Toxicology / TDM 03/03/2006 Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device   K050050 Opiates Toxicology / TDM 03/03/2006 Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device   K050050 Methamphetamines Toxicology / TDM 03/03/2006 Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup   K050878 Amphetamines Toxicology / TDM 02/27/2006 Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup   K050878 Cannabinoids (THC) Toxicology / TDM 02/27/2006 Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup   K050878 Phencyclidine (PCP) Toxicology / TDM 02/27/2006 Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup   K050878 Cocaine Metabolites Toxicology / TDM 02/27/2006 Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup   K050878 Opiates Toxicology / TDM 02/27/2006 Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup   K050878 Methamphetamines Toxicology / TDM 02/27/2006 Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup   K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/27/2006 Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Cassette   K060019 hCG, Urine Endocrinology 02/22/2006 Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Midstream   K060019 hCG, Urine Endocrinology 02/22/2006 Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Strip   K060019 hCG, Urine Endocrinology 02/22/2006 Artron One-Step Pregnancy Test   K060019 hCG, Urine Endocrinology 02/22/2006 Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006 Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006 Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006 Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/22/2006 Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006 Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick pH Urinalysis 02/22/2006 Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006 Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006 Biotechnostix, Inc. Rapid Response Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/22/2006 First Check Diagnostics First Check 12 Drug Test   K052115 Amphetamines Toxicology / TDM 02/22/2006 First Check Diagnostics First Check 12 Drug Test   K052115 Cannabinoids (THC) Toxicology / TDM 02/22/2006 First Check Diagnostics First Check 12 Drug Test   K052115 Phencyclidine (PCP) Toxicology / TDM 02/22/2006 First Check Diagnostics First Check 12 Drug Test   K052115 Cocaine Metabolites Toxicology / TDM 02/22/2006 First Check Diagnostics First Check 12 Drug Test   K052115 Opiates Toxicology / TDM 02/22/2006 First Check Diagnostics First Check 12 Drug Test   K052115 Methadone Toxicology / TDM 02/22/2006 First Check Diagnostics First Check 12 Drug Test   K052115 Methamphetamines Toxicology / TDM 02/22/2006 First Check Diagnostics First Check 12 Drug Test   K052115 Benzodiazepines Toxicology / TDM 02/22/2006 First Check Diagnostics First Check 12 Drug Test   K052115 Barbiturates Toxicology / TDM 02/22/2006 First Check Diagnostics First Check 12 Drug Test   K052115 Tricyclic Antidepressants Toxicology / TDM 02/22/2006 First Check Diagnostics First Check 12 Drug Test   K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/22/2006 First Check Diagnostics First Check 12 Drug Test   K052115 Oxycodone Toxicology / TDM 02/22/2006 Genzyme Sure-Vue Signature MONO Test  (Whole Blood) K972231 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/22/2006 Germaine Laboratories AimStick 10-SG   K051727 Urine Qualitative Dipstick Chemistries Urinalysis 02/22/2006 Germaine Laboratories AimStick US-2   K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Germaine Laboratories AimStick US-2   K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006 Germaine Laboratories AimStick US-2GK   K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006 Germaine Laboratories AimStick US-2GK   K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Germaine Laboratories AimStick US-2GpH   K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Germaine Laboratories AimStick US-2GpH   K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006 Germaine Laboratories AimStick US-2LN   K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 02/22/2006 Germaine Laboratories AimStick US-2LN   K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006 Germaine Laboratories AimStick US-3   K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Germaine Laboratories AimStick US-3   K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006 Germaine Laboratories AimStick US-3   K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006 Germaine Laboratories AimStick US-4   K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006 Germaine Laboratories AimStick US-4   K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Germaine Laboratories AimStick US-4   K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006 Germaine Laboratories AimStick US-4   K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006 Germaine Laboratories AimStick US-4OB   K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Germaine Laboratories AimStick US-4OB   K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 02/22/2006 Germaine Laboratories AimStick US-4OB   K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006 Germaine Laboratories AimStick US-4OB   K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006 Germaine Laboratories AimStick US-5   K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006 Germaine Laboratories AimStick US-5   K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006 Germaine Laboratories AimStick US-5   K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Germaine Laboratories AimStick US-5   K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006 Germaine Laboratories AimStick US-5   K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006 Germaine Laboratories AimStick US-6   K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006 Germaine Laboratories AimStick US-6   K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006 Germaine Laboratories AimStick US-6   K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006 Germaine Laboratories AimStick US-6   K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Germaine Laboratories AimStick US-6   K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006 Germaine Laboratories AimStick US-6   K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006 Germaine Laboratories AimStick US-7   K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006 Germaine Laboratories AimStick US-7   K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006 Germaine Laboratories AimStick US-7   K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006 Germaine Laboratories AimStick US-7   K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Germaine Laboratories AimStick US-7   K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006 Germaine Laboratories AimStick US-7   K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006 Germaine Laboratories AimStick US-7   K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006 Germaine Laboratories AimStick US-8   K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006 Germaine Laboratories AimStick US-8   K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006 Germaine Laboratories AimStick US-8   K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006 Germaine Laboratories AimStick US-8   K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Germaine Laboratories AimStick US-8   K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006 Germaine Laboratories AimStick US-8   K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006 Germaine Laboratories AimStick US-8   K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006 Germaine Laboratories AimStick US-8   K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006 Germaine Laboratories AimStick US-9   K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006 Germaine Laboratories AimStick US-9   K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006 Germaine Laboratories AimStick US-9   K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006 Germaine Laboratories AimStick US-9   K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Germaine Laboratories AimStick US-9   K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006 Germaine Laboratories AimStick US-9   K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006 Germaine Laboratories AimStick US-9   K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006 Germaine Laboratories AimStick US-9   K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006 Germaine Laboratories AimStick US-9   K051727 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/22/2006 Germaine Laboratories AimStick US-B   K051727 Urine Qualitative Dipstick Blood Urinalysis 02/22/2006 Germaine Laboratories AimStick US-BR   K051727 Urine Qualitative Dipstick Bilirubin Urinalysis 02/22/2006 Germaine Laboratories AimStick US-G   K051727 Urine Qualitative Dipstick Glucose Urinalysis 02/22/2006 Germaine Laboratories AimStick US-K   K051727 Urine Qualitative Dipstick Ketone Urinalysis 02/22/2006 Germaine Laboratories AimStick US-L   K051727 Urine Qualitative Dipstick Leukocytes Urinalysis 02/22/2006 Germaine Laboratories AimStick US-N   K051727 Urine Qualitative Dipstick Nitrite Urinalysis 02/22/2006 Germaine Laboratories AimStick US-P   K051727 Urine Qualitative Dipstick Protein Urinalysis 02/22/2006 Germaine Laboratories AimStick US-pH   K051727 Urine Qualitative Dipstick pH Urinalysis 02/22/2006 Germaine Laboratories AimStick US-SG   K051727 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/22/2006 Germaine Laboratories AimStick US-U   K051727 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/22/2006 ImmuLab, Inc. One Step Pregnancy Test Strip (Urine)   K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 02/22/2006 Instant Technologies Inc. One Step LH Ovulation Test Cassette   X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 02/22/2006 Instant Technologies Inc. One Step LH Ovulation Test Strip   X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 02/22/2006 Lifescan One Touch Ultra 2 Blood Glucose Monitoring System   K053529 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/22/2006 RAC Medical Clarity MONO Mononucleosis Rapid Test Device  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/22/2006 Saless Enterprises Inc. One Step LH Ovulation Test Cassette   X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 02/22/2006 Axis-Shield Afinion AS100 Analyzer   K050574 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 02/17/2006 Albertsons Equaline Sidekick Blood Glucose Testing System   K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2006 Chain Drug Consortium Premier Value Sidekick Blood Glucose Testing System   K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD   K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD   K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD   K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD   K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD   K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD   K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (1-4 PARAMETERS) GLUCOSE/ PROTEIN/ NITRITE/ LEUKOCYTE/ KETONE/ PH/ BLOOD   K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES   K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES   K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES   K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES   K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES   K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES   K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES   K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES   K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES   K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/09/2006 CTMI URINALYSIS REAGENT STRIPS (5-10 PARAMETERS) GLUCOSE/ BILIRUBIN/ KETONE/ SPECIFIC GRAVITY/ BLOOD/ PH/ PROTEIN/ UROBILINOGEN/ NITRITE/ LEUKOCYTES   K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin   K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin   K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin   K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin   K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin   K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin   K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite   K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite   K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite   K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite   K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite   K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite   K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite   K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity   K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity   K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity   K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity   K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity   K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity   K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity   K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity   K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen   K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen   K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen   K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen   K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen   K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen   K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen   K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen   K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/09/2006 IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen   K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/09/2006 McKesson SunMark Sidekick Blood Glucose Testing System   K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2006 Safeway Sidekick Blood Glucose Testing System   K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/09/2006 AgaMatrix Liberty Blood Glucose Monitoring System   K052762 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/24/2006 AgaMatrix Liberty Blood Glucose Monitoring System {Professional Use}  K052762 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/24/2006 DE Healthcare Products Ultrascreen 10+SG   K991927 Urine Qualitative Dipstick Ketone Urinalysis 01/24/2006 DE Healthcare Products Ultrascreen 10+SG   K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 01/24/2006 DE Healthcare Products Ultrascreen 10+SG   K991927 Urine Qualitative Dipstick Blood Urinalysis 01/24/2006 DE Healthcare Products Ultrascreen 10+SG   K991927 Urine Qualitative Dipstick Glucose Urinalysis 01/24/2006 DE Healthcare Products Ultrascreen 10+SG   K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 01/24/2006 DE Healthcare Products Ultrascreen 10+SG   K991927 Urine Qualitative Dipstick Nitrite Urinalysis 01/24/2006 DE Healthcare Products Ultrascreen 10+SG   K991927 Urine Qualitative Dipstick pH Urinalysis 01/24/2006 DE Healthcare Products Ultrascreen 10+SG   K991927 Urine Qualitative Dipstick Protein Urinalysis 01/24/2006 DE Healthcare Products Ultrascreen 10+SG   K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/24/2006 DE Healthcare Products Ultrascreen 10+SG   K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/24/2006 DE Healthcare Products Ultrascreen 10+SG   K991927 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 01/24/2006 First Check Diagnostics First Check Multi Drug Cup   K051966 Amphetamines Toxicology / TDM 01/17/2006 First Check Diagnostics First Check Multi Drug Cup   K051966 Cannabinoids (THC) Toxicology / TDM 01/17/2006 First Check Diagnostics First Check Multi Drug Cup   K051966 Phencyclidine (PCP) Toxicology / TDM 01/17/2006 First Check Diagnostics First Check Multi Drug Cup   K051966 Cocaine Metabolites Toxicology / TDM 01/17/2006 First Check Diagnostics First Check Multi Drug Cup   K051966 Opiates Toxicology / TDM 01/17/2006 First Check Diagnostics First Check Multi Drug Cup   K051966 Methamphetamines Toxicology / TDM 01/17/2006 First Check Diagnostics First Check Multi Drug Cup   K051966 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/17/2006 Biotechnostix, Inc. Rapid Response FSH One Step Menopause Test Device  (Professional Use) K041165 Follicle Stimulating Hormone (FSH) Endocrinology 01/10/2006 First Check Multi Drug Cup 12  (OTC) K052115 Amphetamines Toxicology / TDM 01/10/2006 First Check Multi Drug Cup 12  (OTC) K052115 Cannabinoids (THC) Toxicology / TDM 01/10/2006 First Check Multi Drug Cup 12  (OTC) K052115 Phencyclidine (PCP) Toxicology / TDM 01/10/2006 First Check Multi Drug Cup 12  (OTC) K052115 Cocaine Metabolites Toxicology / TDM 01/10/2006 First Check Multi Drug Cup 12  (OTC) K052115 Opiates Toxicology / TDM 01/10/2006 First Check Multi Drug Cup 12  (OTC) K052115 Methadone Toxicology / TDM 01/10/2006 First Check Multi Drug Cup 12  (OTC) K052115 Methamphetamines Toxicology / TDM 01/10/2006 First Check Multi Drug Cup 12  (OTC) K052115 Benzodiazepines Toxicology / TDM 01/10/2006 First Check Multi Drug Cup 12  (OTC) K052115 Barbiturates Toxicology / TDM 01/10/2006 First Check Multi Drug Cup 12  (OTC) K052115 Tricyclic Antidepressants Toxicology / TDM 01/10/2006 First Check Multi Drug Cup 12  (OTC) K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/10/2006 First Check Multi Drug Cup 12  (OTC) K052115 Oxycodone Toxicology / TDM 01/10/2006 RAC Medical Clarity FSH One Step Menopause Test Device  (Professional Use) K041165 Follicle Stimulating Hormone (FSH) Endocrinology 01/10/2006 IND Diagnostic Inc. One Step HCG Pregnancy Test 2000 mIU/mL   K052694 Urine hCG By Visual Color Comparison Tests Endocrinology 12/19/2005 Rapid Response Mononucleosis Rapid Test Device (whole blood)   K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 12/15/2005 Aventir Biotech, LLC Glucose Pilot Monitoring System   K052208 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/12/2005 Sein Electronics Blood Glucose and Blood Pressure Measurement System, Model BGP-100   K052108 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/08/2005 Runbio Biotech Co., Ltd. David Ovulation Test   K053239 Ovulation Test (LH) By Visual Color Comparison Endocrinology 12/07/2005 Runbio Biotech Co., Ltd. David Ovulation Test   K053238 Ovulation Test (LH) By Visual Color Comparison Endocrinology 12/06/2005 IND Diagnostic INC. One Step FSH Menopausal Test (Cassette)   K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005 IND Diagnostic INC. One Step FSH Menopausal Test (midstream)   K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005 IND Diagnostic INC. One Step FSH Menopausal Test (Strip)   K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005 IND Diagnostic, Inc. One Step Cassette Style FSH Menopausal Test  (Professional Use) K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005 IND Diagnostic, Inc. One Step Strip Style FSH Menopausal Test  (Professional Use) K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005 Target Corporation EasyPRO Blood Glucose Mornitoring System   K031388 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/02/2005 BioJENC Uro-nDip UTI Urinalysis Reagent Strip   X050011 Urine Qualitative Dipstick Nitrite Urinalysis 11/29/2005 BioJENC Uro-nDip UTI Urinalysis Reagent Strip   X050011 Urine Qualitative Dipstick pH Urinalysis 11/29/2005 Henry Schein Urispec 11-Way Reagent Strip   K991927 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005 Henry Schein Urispec 11-Way Reagent Strip   K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 11/29/2005 Henry Schein Urispec 11-Way Reagent Strip   K991927 Urine Qualitative Dipstick Blood Urinalysis 11/29/2005 Henry Schein Urispec 11-Way Reagent Strip   K991927 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005 Henry Schein Urispec 11-Way Reagent Strip   K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 11/29/2005 Henry Schein Urispec 11-Way Reagent Strip   K991927 Urine Qualitative Dipstick Nitrite Urinalysis 11/29/2005 Henry Schein Urispec 11-Way Reagent Strip   K991927 Urine Qualitative Dipstick pH Urinalysis 11/29/2005 Henry Schein Urispec 11-Way Reagent Strip   K991927 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005 Henry Schein Urispec 11-Way Reagent Strip   K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/29/2005 Henry Schein Urispec 11-Way Reagent Strip   K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/29/2005 Henry Schein Urispec 11-Way Reagent Strip   K991927 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-1 Parameter Glucose   K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-1 Parameter Ketone   K993850 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Ketone   K993850 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Ketone   K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Protein   K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Protein   K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein   K993850 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein   K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein   K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes   K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes   K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes   K993850 Urine Qualitative Dipstick Nitrite Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes   K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood   K993850 Urine Qualitative Dipstick Blood Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood   K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood   K993850 Urine Qualitative Dipstick pH Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood   K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone   K993850 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone   K993850 Urine Qualitative Dipstick Blood Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone   K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone   K993850 Urine Qualitative Dipstick pH Urinalysis 11/29/2005 IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone   K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005 Worldwide Medical First Check Multi Drug Cup 7  (OTC) K051966 Amphetamines Toxicology / TDM 11/29/2005 Worldwide Medical First Check Multi Drug Cup 7  (OTC) K051966 Cannabinoids (THC) Toxicology / TDM 11/29/2005 Worldwide Medical First Check Multi Drug Cup 7  (OTC) K051966 Phencyclidine (PCP) Toxicology / TDM 11/29/2005 Worldwide Medical First Check Multi Drug Cup 7  (OTC) K051966 Cocaine Metabolites Toxicology / TDM 11/29/2005 Worldwide Medical First Check Multi Drug Cup 7  (OTC) K051966 Opiates Toxicology / TDM 11/29/2005 Worldwide Medical First Check Multi Drug Cup 7  (OTC) K051966 Methamphetamines Toxicology / TDM 11/29/2005 Worldwide Medical First Check Multi Drug Cup 7  (OTC) K051966 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/29/2005 SA Scientific SAS Influenza A Test   K041441 Influenza A Virology 11/23/2005 SA Scientific SAS Influenza B Test   K041439 Influenza B Virology 11/23/2005 QuickVue iFOB Test (Immunochemical Fecal Occult Blood)  (cassette) K021423 Fecal Occult Blood General Chemistry 11/09/2005 Target Corporation EasyPRO Blood Glucose Mornitoring System   K020232 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/09/2005 CAREONE Sidekick Blood Glucose Testing System   K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/20/2005 Fisher Scientific Sure-Vue RSV Test   K022845 Respiratory Syncytial Virus Virology 10/20/2005 Home Diagnostics Inc. Diabetes Centers of America TrueTrack Smart System Blood Glucose Monitoring System   K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/20/2005 Meridian Bioscience ImmunoCard STAT! RSV PLUS   K041445 Respiratory Syncytial Virus Virology 10/20/2005 Remel Xpect Rsv   K022845 Respiratory Syncytial Virus Virology 10/20/2005 SA Scientific SAS RSV Test   K022845 Respiratory Syncytial Virus Virology 10/20/2005 SA Scientific SAS RSVAlert   K022845 Respiratory Syncytial Virus Virology 10/20/2005 Care Fecal Occult Blood Test   K051806 Fecal Occult Blood General Chemistry 10/07/2005 Hypoguard Assure Pro Blood Glucose Monitoring System   K051514 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/07/2005 Instant Technologies iScreen Mononucleosis Rapid Test Device  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 10/07/2005 Instant Technologies iScreen Mononucleosis Rapid Test Strip  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 10/07/2005 Taidoc Prodigy Blood Glucose Monitoring System   K051854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/07/2005 Hemocue Glucose 201 DM Analyzer   K041230 Glucose General Chemistry 09/28/2005 Instant Technologies iScreen H. pylori Rapid Test Device   K024350 Helicobacter Pylori Antibodies General Immunology 09/27/2005 Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips}  K023558 HDL Cholesterol General Chemistry 09/27/2005 Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips}  K023558 Cholesterol General Chemistry 09/27/2005 Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips}  K023558 HDL Cholesterol General Chemistry 09/27/2005 Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips}  K023558 Cholesterol General Chemistry 09/27/2005 ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use) K050878 Amphetamines Toxicology / TDM 09/13/2005 ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use) K050878 Cannabinoids (THC) Toxicology / TDM 09/13/2005 ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use) K050878 Phencyclidine (PCP) Toxicology / TDM 09/13/2005 ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use) K050878 Cocaine Metabolites Toxicology / TDM 09/13/2005 ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use) K050878 Opiates Toxicology / TDM 09/13/2005 ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use) K050878 Methamphetamines Toxicology / TDM 09/13/2005 ACON Multi-Drug Multi-Line Screen Test Card With Integrated Cup  (Professional Use) K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/13/2005 Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters   K993850 Urine Qualitative Dipstick Ketone Urinalysis 09/12/2005 Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters   K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 09/12/2005 Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters   K993850 Urine Qualitative Dipstick Blood Urinalysis 09/12/2005 Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters   K993850 Urine Qualitative Dipstick Glucose Urinalysis 09/12/2005 Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters   K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 09/12/2005 Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters   K993850 Urine Qualitative Dipstick Nitrite Urinalysis 09/12/2005 Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters   K993850 Urine Qualitative Dipstick pH Urinalysis 09/12/2005 Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters   K993850 Urine Qualitative Dipstick Protein Urinalysis 09/12/2005 Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters   K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/12/2005 Waypoint Biomedical Urinalysis Reagent Strips, 10 Parameters   K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/12/2005 CVS Sidekick Blood Glucose Test System  (Over-The-Counter) K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2005 Good Neighbor Pharmacy Sidekick Blood Glucose Test System  (Over-The-Counter) K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2005 International Newtech Develop. Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Ketone Urinalysis 09/09/2005 International Newtech Develop. Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 09/09/2005 International Newtech Develop. Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Blood Urinalysis 09/09/2005 International Newtech Develop. Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Glucose Urinalysis 09/09/2005 International Newtech Develop. Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 09/09/2005 International Newtech Develop. Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Nitrite Urinalysis 09/09/2005 International Newtech Develop. Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick pH Urinalysis 09/09/2005 International Newtech Develop. Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Protein Urinalysis 09/09/2005 International Newtech Develop. Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/09/2005 International Newtech Develop. Urinalysis Reagent Strips   K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/09/2005 Leader Sidekick Blood Glucose Test System  (Over-The-Counter) K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2005 Walgreens Sidekick Blood Glucose Test System  (Over-The-Counter) K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2005 Roche Diagnostics Accu-Chek Go Blood Glucose Monitoring System   K051592 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/08/2005 Bayer Clinitek Status Urine Chemistry Analyzer   K031947 Urine Qualitative Dipstick Bilirubin Urinalysis 09/07/2005 Bayer Clinitek Status Urine Chemistry Analyzer   K031947 Urine Qualitative Dipstick Blood Urinalysis 09/07/2005 Bayer Clinitek Status Urine Chemistry Analyzer   K031947 Urine Qualitative Dipstick Glucose Urinalysis 09/07/2005 Bayer Clinitek Status Urine Chemistry Analyzer   K031947 Urine Qualitative Dipstick Leukocytes Urinalysis 09/07/2005 Bayer Clinitek Status Urine Chemistry Analyzer   K031947 Urine Qualitative Dipstick Nitrite Urinalysis 09/07/2005 Bayer Clinitek Status Urine Chemistry Analyzer   K031947 Urine Qualitative Dipstick pH Urinalysis 09/07/2005 Bayer Clinitek Status Urine Chemistry Analyzer   K031947 Urine Qualitative Dipstick Protein Urinalysis 09/07/2005 Bayer Clinitek Status Urine Chemistry Analyzer   K031947 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/07/2005 Bayer Clinitek Status Urine Chemistry Analyzer   K031947 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/07/2005 Bayer Clinitek Status Urine Chemistry Analyzer   K031947 Urine Qualitative Dipstick Creatinine Urinalysis 09/07/2005 Bayer Clinitek Status Urine Chemistry Analyzer   K031947 Urine Qualitative Dipstick Ketone Urinalysis 09/07/2005 accutest Multi-Drug, Multi-Line Screen Device   K050050 Amphetamines Toxicology / TDM 09/01/2005 accutest Multi-Drug, Multi-Line Screen Device   K050050 Cannabinoids (THC) Toxicology / TDM 09/01/2005 accutest Multi-Drug, Multi-Line Screen Device   K050050 Phencyclidine (PCP) Toxicology / TDM 09/01/2005 accutest Multi-Drug, Multi-Line Screen Device   K050050 Cocaine Metabolites Toxicology / TDM 09/01/2005 accutest Multi-Drug, Multi-Line Screen Device   K050050 Opiates Toxicology / TDM 09/01/2005 accutest Multi-Drug, Multi-Line Screen Device   K050050 Methamphetamines Toxicology / TDM 09/01/2005 ACON Mononucleosis Rapid Test Device  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 09/01/2005 ACON Mononucleosis Rapid Test Strip  (Whole Blood) K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 09/01/2005 RediScreen Multi-Drug, Multi-Line Screen Test Device   K050050 Amphetamines Toxicology / TDM 09/01/2005 RediScreen Multi-Drug, Multi-Line Screen Test Device   K050050 Cannabinoids (THC) Toxicology / TDM 09/01/2005 RediScreen Multi-Drug, Multi-Line Screen Test Device   K050050 Phencyclidine (PCP) Toxicology / TDM 09/01/2005 RediScreen Multi-Drug, Multi-Line Screen Test Device   K050050 Cocaine Metabolites Toxicology / TDM 09/01/2005 RediScreen Multi-Drug, Multi-Line Screen Test Device   K050050 Opiates Toxicology / TDM 09/01/2005 RediScreen Multi-Drug, Multi-Line Screen Test Device   K050050 Methamphetamines Toxicology / TDM 09/01/2005 Biosite Triage Meter  (Whole Blood) K021317 B-Type Natriuretic Peptide (BNP) General Chemistry 08/26/2005 Biosite Triage Meter Plus  (Whole Blood) K021317 B-Type Natriuretic Peptide (BNP) General Chemistry 08/26/2005 Acon Laboratories, Inc. FSH One Step Menopause Test Device  (Professional Use) K041165 Follicle Stimulating Hormone (FSH) Endocrinology 08/24/2005 Acon Laboratories, Inc. FSH One Step Menopause Test Strip  (Professional Use) K041165 Follicle Stimulating Hormone (FSH) Endocrinology 08/24/2005 Roche Diagnostics AccuChek Instant Plus Dual Testing System   K051376 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/24/2005 Roche Diagnostics AccuChek Instant Plus Dual Testing System   K051376 Cholesterol General Chemistry 08/24/2005 Brooks Pharmacy Sidekick Blood Glucose Test System   K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005 Eckerd Pharmacy Sidekick Blood Glucose Test System   K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005 McKesson SunMark Performance Plus Sidekick Blood Glucose Test System   K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005 Medicine Shoppe Sidekick Blood Glucose Test System   K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005 Meijer Sidekick Blood Glucose Test System   K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005 WH Accu Test One-Step Urine/Serum Pregnancy Test   K051841 Urine hCG By Visual Color Comparison Tests Endocrinology 08/22/2005 Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 08/16/2005 Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) K942782 Glucose General Chemistry 08/16/2005 Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood) K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 08/16/2005 Abbott Freestyle Connect Blood Glucose Monitoring System   K051802 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/11/2005 BIOMEDIX INC. Q STEPS Biometer G/C Dual Monitoring System   K050182 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/11/2005 BIOMEDIX INC. Q STEPS Biometer G/C Dual Monitoring System   K050182 Cholesterol General Chemistry 08/11/2005 Taidoc Clever Chek TD-3215 Blood Glucose and Blood Pressure Measurement System   K051936 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/11/2005 Taidoc Dr. T TD-3216 Blood Glucose and Blood Pressure Measurement System   K051936 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/11/2005 Infopia Co., Ltd. GLucoLab Blood Glucose Monitoring System {Home Use}  K051285 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/09/2005 Infopia Co., Ltd. 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InstaRead Lithium System  (fingerstick or venipuncture whole blood) K031579 Lithium Toxicology / TDM 04/22/2005 Biotechnostix Rapid Response Strep A Rapid Test Device   K023766 Streptococcus, Group A Bacteriology 04/21/2005 Biotechnostix Rapid Response Strep A Rapid Test Strip   K010582 Streptococcus, Group A Bacteriology 04/21/2005 RAC Medical Clarity Strep A Rapid Test Strips   K010582 Streptococcus, Group A Bacteriology 04/21/2005 RAC Medical Clarity Strep A Twist Rapid Test Device   K023766 Streptococcus, Group A Bacteriology 04/21/2005 US Diagnostics, Inc. EASYGLUCO Blood Monitoring System   K043512 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/21/2005 US Diagnostics, Inc. 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