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CLIA - Tests waived by FDA from January 2000 to present

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Tests can be categorized as "waived" from regulatory oversite if they meet certain requirements established by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) law. By selecting a Test System Name, you can view the CLIA data for that Test System, including the corresponding 510(K) record, if applicable. The information is sorted first by the date of Categorization of the Test, then by Test System Name. This list does not include Test Systems that were characterized by the CDC prior to January 2000.
 
 
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Show All Test Systems Download Files | More About CLIA
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Bayer Contour USB Glucose Monitoring System  
K091820 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2009
BinaxNOW Influenza A & B Test  
K092223 Influenza A/B Virology 08/18/2009
BTNX Inc. Rapid Response hCG Pregnancy Serum/Urine Test Strip  
K974060 Urine hCG By Visual Color Comparison Tests Endocrinology 07/01/2009
BTNX Inc. Rapid Response hCG Pregnancy Test (Midstream)  
K974059 Urine hCG By Visual Color Comparison Tests Endocrinology 04/30/2009
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
BTNX Rapid Response hCG Pregnancy Urine Cassette and Dipstick Tests  
K070921 Urine hCG By Visual Color Comparison Tests Endocrinology 01/26/2009
BTNX Inc. Rapid Response hCG Pregnancy Serum/Urine Test Cassette and Dipstick Tests  
K071030 Urine hCG By Visual Color Comparison Tests Endocrinology 01/05/2009
BTNX Inc. Rapid Response hCG Pregnancy Test 2000 mIU/mL  
K052694 Urine hCG By Visual Color Comparison Tests Endocrinology 01/05/2009
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
Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM100  
K081451 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/25/2008
Bionime Corporation Rightest Blood Glucose Monitoring System, Model GM110  
K081450 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/12/2008
BTNX Inc. Rapid Response Immunological Fecal Occult Blood Test (IFOBT)  
K061065 Fecal Occult Blood General Chemistry 07/22/2008
BECKMAN COULTER HEMOCCULT ICT  
K080812 Fecal Occult Blood General Chemistry 07/01/2008
Bayer A1CNow +  (For professional use)
K051321 Glycated Hemoglobin, Total General Chemistry 03/31/2008
Bestgen Major III Blood Glucose Monitoring System  
K072274 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/04/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Amphetamines Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Cannabinoids (THC) Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Phencyclidine (PCP) Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Cocaine Metabolites Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methadone Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methamphetamines Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Benzodiazepines Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Barbiturates Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Morphine Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Tricyclic Antidepressants Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Amphetamines Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Cannabinoids (THC) Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Phencyclidine (PCP) Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Cocaine Metabolites Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methadone Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methamphetamines Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Benzodiazepines Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Barbiturates Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Morphine Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Tricyclic Antidepressants Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/30/2008
Becton Dickinson BD Chek Group A Strep Test  
K010582 Streptococcus, Group A Bacteriology 01/22/2008
BTNX Inc. Rapid Response H. pylori Whole Blood Rapid Test Device  
K024360 Helicobacter Pylori Antibodies General Immunology 01/15/2008
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
BinaxNOW Influenza A & B Test  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens and Nasal Swabs (NS))
K062109 Influenza A/B Virology 11/01/2007
BTNX Inc. Clarity Fecal Occult Blood (FOB) Self Test  
K070660 Fecal Occult Blood General Chemistry 10/05/2007
BTNX Inc. Know Fecal Occult Blood (FOB) Self Test  
K070660 Fecal Occult Blood General Chemistry 10/05/2007
BTNX Inc. Rapid Response Fecal Occult Blood (FOB) Self Test  
K070660 Fecal Occult Blood General Chemistry 10/05/2007
Bionexia hCG Pregnancy Serum/Urine Cassette and Dipstick Tests  
K071030 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2007
BTNX Inc. Rapid Response Blood Glucose Monitoring System  
K051854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/12/2007
Bionime Corporation Rightest Blood Glucose Monitoring System  
K062567 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/29/2007
Bayer Clinitek Status Urine Chemistry Analyzer  
K032563 hCG, Urine Endocrinology 03/16/2007
Bayer Diagnostics Ascencia BREEZE 2 Blood Glucose Monitoring System  
K062347 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/22/2006
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
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
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
Biosite Triage Meterpro  (Whole Blood)
K021317 B-Type Natriuretic Peptide (BNP) General Chemistry 10/04/2006
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
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
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
BinaxNOW Influenza A & B Test  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens)
K053126 Influenza A/B Virology 04/19/2006
Bioptik Technology, Inc. EasyMate Blood Glucose Monitoring System  
K053312 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/09/2006
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
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
Biotechnostix, Inc. Rapid Response FSH One Step Menopause Test Device  (Professional Use)
K041165 Follicle Stimulating Hormone (FSH) Endocrinology 01/10/2006
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
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
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
Brooks Pharmacy Sidekick Blood Glucose Test System  
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2005
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
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Amphetamines Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Cannabinoids (THC) Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Phencyclidine (PCP) Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Cocaine Metabolites Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Opiates Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Methadone Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Methamphetamines Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Benzodiazepines Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Barbiturates Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/19/2005
Branan Medical Corporation ToxCup Drug Screen Cup  
K032057 Oxycodone Toxicology / TDM 07/19/2005
Bioscreen Medical One Step Cassette Style hCG Urine (Home) Pregnancy Test  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Bioscreen Medical One Step hCG Pregnancy Urine Test Cassette  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Bioscreen Medical One Step hCG Pregnancy Urine Test Strip  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Bioscreen Medical One Step hCG Pregnancy Urine/Serum Test Cassette  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Bioscreen Medical One Step hCG Pregnancy Urine/Serum Test Strip  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Bioscreen Medical One Step Midstream Style hCG Urine (Home) Pregnancy Test  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
Bioscreen Medical One Step Strip Style hCG Urine (Home) Pregnancy Test  
K050305 Urine hCG By Visual Color Comparison Tests Endocrinology 06/10/2005
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
Brooks Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Ketone Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Bilirubin Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Blood Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Glucose Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Leukocytes Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Nitrite Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick pH Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Protein Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/18/2005
BioSys Laboratories, Inc. UriScan Optima II Urine Analyzer  
K980047 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/18/2005
BAYER RELI-ON KETONE TEST STRIPS  
K801270 Ketone, Urine General Chemistry 02/14/2005
Binax NOW RSV Test  
K032166 Respiratory Syncytial Virus Virology 01/28/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Amphetamines Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Cannabinoids (THC) Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Phencyclidine (PCP) Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Cocaine Metabolites Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Opiates Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Methadone Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Methamphetamines Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Benzodiazepines Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Barbiturates Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Tricyclic Antidepressants Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/26/2005
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K022355 Oxycodone Toxicology / TDM 01/26/2005
Beckman Coulter, ICON Mono  
X040027 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/24/2005
Bionime Corporation Rightest Blood Glucose Monitoring System  
K042678 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/06/2005
BAYER DIAGNOSTICS ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM  
K043158 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/29/2004
BAYER DIAGNOSTICS ASCENSIA ELITE DIABETES CARE SYSTEM  
K043311 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/29/2004
BIOSAFE LABORTORIES, INC., ANEMIAPRO SELF SCREENER  
K042379 Hemoglobin Hematology 12/22/2004
BinaxNOW Influenza A & B Test  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens)
K041049 Influenza A/B Virology 12/01/2004
BECKMAN COULTER ICON DS STREP A  
K983386 Streptococcus, Group A Bacteriology 10/29/2004
BECKMAN COULTER, INC. ICON 20 HCG SERUM/URINE TEST  
K020439 Urine hCG By Visual Color Comparison Tests Endocrinology 10/29/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Ketone Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Bilirubin Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Blood Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Glucose Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Leukocytes Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Nitrite Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick pH Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Protein Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/27/2004
BIOSYS LABORATORIES OPTIMA II URINE ANALYZER  
K980047 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/27/2004
BRISTOL-MYERS SQUIBB CO. CHOICE DM  
K033847 Glycated Hemoglobin, Total General Chemistry 08/26/2004
BECKMAN COULTER HEMOCCULT ICT  
K961062 Fecal Occult Blood General Chemistry 06/28/2004
BECKMAN COULTER ICON II HCG  (urine/serum)
K860542 Urine hCG By Visual Color Comparison Tests Endocrinology 06/23/2004
BECKMAN COULTER ICON II HCG (URINE)  
K865057 Urine hCG By Visual Color Comparison Tests Endocrinology 06/22/2004
BECKMAN COULTER HEMOCCULT ICT  
K961062 Fecal Occult Blood General Chemistry 05/26/2004
Becton Dickinson, Paradigm Link Blood Glucose Monitor  
K040603 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/19/2004
BT MEDICAL, BTG SMARTEST BLOOD GLUCOSE MONITORING SYSTEM  
K032029 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/08/2004
BIOTECH ATLANTIC INC UNIMARK ONE STEP HOME PREGNANCY TEST DEVICE  (cassette)
K032992 hCG, Urine Endocrinology 12/09/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Ketone Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Bilirubin Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Blood Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Glucose Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Leukocytes Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Nitrite Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick pH Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Protein Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/25/2003
BIOSYS LABORATORIES OPTIMA URINE ANALYZER  
K980047 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/25/2003
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS ICON SC STREP A TEST  
K023766 Streptococcus, Group A Bacteriology 09/25/2003
Binax NOW RSV Test  
K021687 Respiratory Syncytial Virus Virology 08/21/2003
Beckman Coulter ICON SC Strep A test  
K023766 Streptococcus, Group A Bacteriology 08/08/2003
BAYER ASCENSIA CONTOUR DIABETES CARE SYSTEM  
K023657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2003
BECKMAN COULTER ICON MICROALB  
K022538 Albumin, Urinary General Chemistry 05/13/2003
BINAX NOW FLU A TEST  
K021649 Influenza A Virology 05/08/2003
Binax NOW Flu B Test {Nashal Wash, Nasopharyngeal} 
K021646 Influenza B Virology 05/08/2003
BAYER DIAGNOSTICS ASCENCIA BREEZE BLOOD GLUCOSE METER  
K024062 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2003
BAYER DIAGNOSTICS CLINITEST HCG PREGNANCY TEST  
K023944 Urine hCG By Visual Color Comparison Tests Endocrinology 02/12/2003
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS HEMOCCULT II SENSA ELITE  
K880499 Fecal Occult Blood General Chemistry 01/13/2003
BIO-RAD MICROMAT II HEMOGLOBIN A1C PRESCRIPTION HOME USE TEST  
K021935 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 12/17/2002
BECTON DICKINSON LATITUDE DIABETES MANAGEMENT SYSTEM  
K022580 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/08/2002
BECTON DICKINSON LOGIC GLUCOSE MONITOR  
K022581 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/08/2002
BIOTEST HEMOGLOBIN MEASURING SYSTEM  
K020710 HGB, SINGLE ANALYTE INST. W/SELF-CONT... Hematology 08/29/2002
Bayer Diagnostics Ascensia DEX 2 Diabetes Care System  
K963500 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/14/2002
BAYER DIAGNOSTICS GLUCODISC BLOOD GLUCOSE TEST STRIPS  
K012205 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/14/2002
BAYER DIAGNOSTICS ASCENCIA ELITE BLOOD GLUCOSE METER  
K990649 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/06/2002
BAYER DIAGNOSTICS ASCENCIA ELITE XL BLOOD GLUCOSE METER  
K990649 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/06/2002
BAYER DIAGNOSTICS ASCENSIA ELITE BLOOD GLUCOSE TEST STRIPS  
K991242 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/06/2002
BAYER DIAGNOSTICS ASCENSIA ELITE DIABETES CARE SYSTEM  
K951537 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/06/2002
BAYER GLUCOMETER DEX 2  
K020210 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2002
BAYER GLUCOMETER DEX DIABETES CARE SYSTEM  
K020210 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2002
BAYER GLUCOMETER DEX TEST SENSOR  
K020210 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2002
BAYER GLUCOMETER ELITE DIABETES CARE SYSTEM  
K020208 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2002
BAYER GLUCOMETER ELITE TEST STRIPS  
K020208 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2002
BAYER GLUCOMETER ELITE XL DIABETES CARE SYSTEM  
K020208 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/01/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Ketone Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Bilirubin Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Blood Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Glucose Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Leukocytes Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Nitrite Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick pH Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Protein Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/26/2002
BAYER NEW MULTIPLES REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Creatinine Urinalysis 02/26/2002
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS ICON DS STREP A  
K010582 Streptococcus, Group A Bacteriology 12/18/2001
BAYER GLUCOMETER DEX 2  
K963500 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/07/2001
BIOCARE CORP. URIMATE REAGENT STRIP FOR URINALYSIS  
K012829 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 11/06/2001
BION DIAGNOSTIC SCIENCES POLY STAT HCG TEST  
K012559 Urine hCG By Visual Color Comparison Tests Endocrinology 10/15/2001
BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST DEVICE  
K013194 hCG, Urine Endocrinology 10/15/2001
BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST STRIP  
K013194 hCG, Urine Endocrinology 10/15/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS HEMOCCULT SENSA  
K880499 Fecal Occult Blood General Chemistry 10/05/2001
BERGEN BRUNSWIG TEST FOR FECAL OCCULT BLOOD  
K911075 Fecal Occult Blood General Chemistry 09/27/2001
BAYER GLUCOMETER DEX TEST SENSOR  
K012205 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/31/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS GASTROCCULT  
K821884 Gastric Occult Blood General Chemistry 08/30/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS GASTROCCULT  
K821884 Gastric pH General Chemistry 08/30/2001
BRITE-LIFE BLOOD GLUCOSE SYSTEM IQ  
K010403 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/03/2001
BIOMEDICAL PRODUCTS DOUBLE-CHEK STRIP URINALYSIS  
K993850 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 06/12/2001
BAYER MULTISTIX PRO 10LS REAGENT STRIPS  
K992257 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 05/01/2001
BAYER MULTISTIX PRO 10LS REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Creatinine Urinalysis 05/01/2001
BAYER MULTISTIX PRO 11 REAGENT STRIPS  
K992257 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 05/01/2001
BAYER MULTISTIX PRO 11 REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Creatinine Urinalysis 05/01/2001
BAYER MULTISTIX PRO 7G REAGENT STRIPS  
K992257 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 05/01/2001
BAYER MULTISTIX PRO 7G REAGENT STRIPS  
K992257 Urine Qualitative Dipstick Creatinine Urinalysis 05/01/2001
BECKMAN COULTER ICON DS HCG TEST STRIP  (urine)
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 04/23/2001
BECKMAN COULTER PRIMARY CARE DIAGNOSTICS ICON FX STREP A IMMUNOCHEMICAL STREP A ANTIGEN TEST  
K960712 Streptococcus, Group A Bacteriology 03/16/2001
BIOMERICA EZ-HCG URINE (PREGNANCY TEST)  
K003856 Urine hCG By Visual Color Comparison Tests Endocrinology 02/26/2001
BAYER MICROALBUSTIX REAGENT STRIPS (OTC)  
K991315 Microalbumin General Chemistry 02/14/2001
BAYER MICROALBUSTIX REAGENT STRIPS (OTC)  
K991315 Creatinine General Chemistry 02/14/2001
BECKMAN COULTER INC'S ICON 25 HCG  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 12/06/2000
BECKMAN COULTER INC'S ICON 25 HCG  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 12/04/2000
BRITE-LIFE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2000
 
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