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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
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
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
Arkray USA Inc. Assure Pro Blood Glucose Monitoring System  
K090332 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/01/2009
All Medicus Gluco Dr. Plus+ Blood Glucose Monitoring System  
K082328 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/12/2009
Abbott OptiumEZ Blood Glucose Monitoring System  
K081975 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2009
All Medicus GlucoDr auto Blood Glucose Test System  
K083628 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/07/2009
Acon Laboratories, On-Call Plus Blood Glucose Monitoring System  
K090057 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
Acceava Mono II  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 04/14/2009
Acceava Strep A Twist Rapid Test {Streptococcus, Group A} 
K010582 Streptococcus, Group A Bacteriology 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
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
AgaMatrix WaveSense AMP Blood Glucose Monitoring System  
K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/02/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Amphetamines Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Phencyclidine (PCP) Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Cocaine Metabolites Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Methadone Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Methamphetamines Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Benzodiazepines Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Barbiturates Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Morphine Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Tricyclic Antidepressants Toxicology / TDM 01/07/2009
Aventir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Oxycodone Toxicology / TDM 01/07/2009
Avnetir Biotech LLC Home Check Multiple Drug Cup Test  (Professional version)
K071489 Cannabinoids (THC) Toxicology / TDM 01/07/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Amphetamines Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Cannabinoids (THC) Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Phencyclidine (PCP) Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Cocaine Metabolites Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Opiates Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Methadone Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Methamphetamines Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Benzodiazepines Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Barbiturates Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Tricyclic Antidepressants Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/05/2009
Amedica Biotech The Amedica Home Drug Test Cup  
K082898 Oxycodone Toxicology / TDM 01/05/2009
Abbott ReliOn Ultima Advance Blood Glucose Monitoring System  
K081975 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/08/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782 Albumin General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782 Glucose General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782 Creatinine General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782 Urea (BUN) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782 Glucose General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782 potassium General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782 Creatinine General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782 Urea (BUN) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K950164 Calcium, Total General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K992140 potassium General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K992140 Creatine Kinase (CK) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K010670 chloride General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K010670 chloride General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K022312 Phosphorus General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K993211 Sodium General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K993211 Sodium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K993211 Sodium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K992140 potassium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K993211 Sodium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K022312 Phosphorus General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K010670 chloride General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K010670 chloride General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K992140 Creatine Kinase (CK) General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K950164 Calcium, Total General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782 Glucose General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782 potassium General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782 Creatinine General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782 Urea (BUN) General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782 Albumin General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782 Glucose General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782 Creatinine General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer {Piccolo Renal Function Panel} (Whole Blood)
K942782 Urea (BUN) General Chemistry 12/04/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110 Hemoglobin Hematology 11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110 Glucose General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110 Sodium General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110 potassium General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110 Urea (BUN) General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110 chloride General Chemistry 11/13/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110 Hematocrit Hematology 11/13/2008
Abbott i-STAT Crea Cartridge  (Venous Whole blood)
K053110 Creatinine General Chemistry 11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous Whole blood)
K053110 Hemoglobin Hematology 11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous Whole blood)
K053110 Sodium General Chemistry 11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous Whole blood)
K053110 potassium General Chemistry 11/13/2008
Abbott i-STAT E3+ Cartridge  (Venous Whole blood)
K053110 Hematocrit Hematology 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110 Hemoglobin Hematology 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110 Glucose General Chemistry 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110 Sodium General Chemistry 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110 potassium General Chemistry 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110 Hematocrit Hematology 11/13/2008
Abbott i-STAT G Cartridge  (Venous Whole blood)
K053110 Glucose General Chemistry 11/13/2008
Arkray USA, Inc. GLUCOCARD 01-mini Blood Glucose Monitoring System  
K082417 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
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
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
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Amphetamines Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Phencyclidine (PCP) Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Cocaine Metabolites Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Methadone Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Methamphetamines Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Benzodiazepines Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Barbiturates Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Morphine Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Tricyclic Antidepressants Toxicology / TDM 07/31/2008
Aventir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Oxycodone Toxicology / TDM 07/31/2008
Avnetir Biotech LLC Home Check Multiple Drug Cup Test  
K071489 Cannabinoids (THC) Toxicology / TDM 07/31/2008
Arkray USA, Inc. GLUCOCARD 01 Blood Glucose Monitoring System  
K073416 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/17/2008
AZO Test Strips Urinary Tract Infection Test  
K063295 Nitrite, Urine General Chemistry 06/25/2008
AZO Test Strips Urinary Tract Infection Test  
K063295 Leukocyte Esterase, Urinary Urinalysis 06/25/2008
AgaMatrix WaveSense KeyNote Pro Blood Glucose Monitoring System  
K052762 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/24/2008
AgaMatrix WaveSense Presto Blood Glucose Monitoring System  
K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/24/2008
Apex Biotechnology Corp. GlucoSure Voice Blood Glucose Monitoring System  
K073137 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)
K023642 Cholesterol 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 xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023642 Cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023642 Cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023639 Triglyceride General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023639 Triglyceride General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023640 HDL Cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023640 HDL Cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {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
AmeriTek dBest One Step Occult Blood Test  
K071242 Fecal Occult Blood General Chemistry 03/12/2008
AgaMatrix WaveSense KeyNote Codeless Blood Glucose Monitoring System  
K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/31/2008
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
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K072836 HDL Cholesterol General Chemistry 01/08/2008
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Abaxis Piccolo xpress Chemistry Analyzer {General Chemistry 13 Panel} (Whole Blood)
K950164 Calcium, Total General Chemistry 03/14/2007
Apex Biotechnology Corp. Assure 4 Blood Glucose Monitoring System  
K070088 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/22/2007
Apex Biotechnology Corp. Gluco Track Blood Glucose Monitoring System  
K062799 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/05/2007
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 13 Panel} (Whole Blood)
K955770 Gamma Glutamyl Transferase (GGT) 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 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)
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  
K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K950164 Alkaline Phosphatase (ALP) General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K950164 Amylase General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K942782 Albumin General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K942782 Protein, Total General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K942782 Glucose General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K942782 Bilirubin, Total General Chemistry 01/22/2007
Abaxis, Piccolo xpress Chemistry Analyzer  
K023642 Cholesterol 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
Arkray, Ferrara Blood Glucose Monitoring System  
K063068 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 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
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
All Medicus GlucoDr SuperSensor Blood Glucose Test System  
K050985 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/20/2006
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
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)
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
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)
K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 10/04/2006
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K050077 Urea (BUN) General Chemistry 10/04/2006
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
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
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
Abbott Freestyle Feedom Blood Glucose Monitoring System  
K051839 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/13/2006
Ani Biotech Oy MySet Pregnancy Test  
K053138 hCG, Urine Endocrinology 03/03/2006
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
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
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
Aventir Biotech, LLC Glucose Pilot Monitoring System  
K052208 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/12/2005
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
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
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
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 08/16/2005
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
Abbott Freestyle Connect Blood Glucose Monitoring System  
K051802 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/11/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K042443 Triglyceride General Chemistry 07/12/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K042443 HDL Cholesterol General Chemistry 07/12/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K042443 Cholesterol General Chemistry 07/12/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K040332 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 07/12/2005
Arkray SPOTCHEM EZ Chemistry Analyzer  (Whole Blood)
K040332 Glucose General Chemistry 07/12/2005
Acon Laboratories, Inc. On Call Home Drug Test for Marijuana  
K050936 Cannabinoids (THC) Toxicology / TDM 06/30/2005
Acon Laboratories, Inc. On Call Home Drug Test for Marijuana and Cocaine  
K050936 Cannabinoids (THC) Toxicology / TDM 06/30/2005
Acon Laboratories, Inc. On Call Home Drug Test for Marijuana and Cocaine  
K050936 Cocaine Metabolites Toxicology / TDM 06/30/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878 Amphetamines Toxicology / TDM 06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878 Cannabinoids (THC) Toxicology / TDM 06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878 Phencyclidine (PCP) Toxicology / TDM 06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878 Cocaine Metabolites Toxicology / TDM 06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878 Opiates Toxicology / TDM 06/10/2005
ACON Laboratories, On Call Multi-Drug Home Test Cup  
K050878 Methamphetamine/Amphetamine Toxicology / TDM 06/10/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (Professional Use)
K050050 Amphetamines Toxicology / TDM 06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (Professional Use)
K050050 Cannabinoids (THC) Toxicology / TDM 06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (Professional Use)
K050050 Phencyclidine (PCP) Toxicology / TDM 06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (Professional Use)
K050050 Cocaine Metabolites Toxicology / TDM 06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (Professional Use)
K050050 Opiates Toxicology / TDM 06/03/2005
Acon One Step Multi-Drug, Multi-Line Screen Test Device  (Professional Use)
K050050 Methamphetamines Toxicology / TDM 06/03/2005
Acon +/- Pregnancy Test  
K050546 hCG, Urine Endocrinology 05/23/2005
AFW Alliance Health Care America TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Albertson's Inc. Sav-On Osco By Albertson's TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
AmerisourceBergen Brite-Life TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
AmerisourceBergen Good Neighbor Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Accumetrics VerifyNow-Aspirin Assay  
K042423 Platelet Aggregation Hematology 03/22/2005
ACON Laboratories, On Call Multi-Drug Home Test  
K050050 Amphetamines Toxicology / TDM 03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test  
K050050 Cannabinoids (THC) Toxicology / TDM 03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test  
K050050 Phencyclidine (PCP) Toxicology / TDM 03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test  
K050050 Cocaine Metabolites Toxicology / TDM 03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test  
K050050 Opiates Toxicology / TDM 03/16/2005
ACON Laboratories, On Call Multi-Drug Home Test  
K050050 Methamphetamines Toxicology / TDM 03/16/2005
Access Bio Inc. CareStart PLUS Pregnancy Test  
K032159 hCG, Urine Endocrinology 02/28/2005
Access Bio Inc. CareStart Pregnancy Test  
K032159 hCG, Urine Endocrinology 02/28/2005
ALFA SCIENTIFIC DESIGNS - ISCREEN FECAL OCCULT BLOOD TEST  
K021423 Fecal Occult Blood General Chemistry 02/25/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE  
K040629 Amphetamines Toxicology / TDM 02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE  
K040629 Cannabinoids (THC) Toxicology / TDM 02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE  
K040629 Phencyclidine (PCP) Toxicology / TDM 02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE  
K040629 Cocaine Metabolites Toxicology / TDM 02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE  
K040629 Opiates Toxicology / TDM 02/17/2005
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES AND PHENCYCLIDINE  
K040629 Methamphetamines Toxicology / TDM 02/17/2005
ACON SPECTRUM MIDSTREAM PREGNANCY TEST  
K042151 Urine hCG By Visual Color Comparison Tests Endocrinology 02/15/2005
AZOG One Step hCG Home Pregnacy Test Device (Urine)  
K041748 Urine hCG By Visual Color Comparison Tests Endocrinology 02/14/2005
AZOG One Step hCG Home Pregnacy Test Strip (Urine)  
K041748 Urine hCG By Visual Color Comparison Tests Endocrinology 02/14/2005
AZOG One Step hCG Pregnacy Test Midstream (Urine)  
K041748 Urine hCG By Visual Color Comparison Tests Endocrinology 02/14/2005
ALFA SCIENTIFIC DESIGNS INSTANT VIEW H. PYLORI WHOLE BLOOD RAPID TEST  
K024360 Helicobacter Pylori Antibodies General Immunology 02/01/2005
APPLIED BIOTECH ONE STEP+ MONO TEST  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 10/15/2004
APPLIED BIOTECH TRUVIEW MONO TEST  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 10/15/2004
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE  
K041946 Urine hCG By Visual Color Comparison Tests Endocrinology 09/10/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA (THC)  
K040327 Cannabinoids (THC) Toxicology / TDM 08/24/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA (THC) AND COCAINE (COC)  
K040327 Cannabinoids (THC) Toxicology / TDM 08/24/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST FOR MARIJUANA (THC) AND COCAINE (COC)  
K040327 Cocaine Metabolites Toxicology / TDM 08/24/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Amphetamines Toxicology / TDM 08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Cannabinoids (THC) Toxicology / TDM 08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Phencyclidine (PCP) Toxicology / TDM 08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Cocaine Metabolites Toxicology / TDM 08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Opiates Toxicology / TDM 08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Methamphetamines Toxicology / TDM 08/19/2004
ACCU-STAT DRUGS OF ABUSE HOME TEST CUP FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, ECSTASY, OPIATES, AND PHENCYCLIDINE  
K041221 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 08/19/2004
Apex Biotechnology Corporation {Hypoguard Assure 3 Blood Glucose Monitoring System} 
K011233 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/05/2004
Apex Biotechnology Corporation {Hypoguard Assure 3 Blood Glucose Monitoring System} 
K002621 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/29/2004
APPLIED BIOTECH SURESTEP EXACT STREP A TEST  
K033855 Streptococcus, Group A Bacteriology 07/26/2004
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023640 HDL Cholesterol General Chemistry 07/09/2004
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023639 Triglyceride General Chemistry 07/09/2004
Abaxis Piccolo Point of Care Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023642 Cholesterol General Chemistry 07/09/2004
ACON LABORATORIES, INC. FSH MENOPAUSE PREDICTOR TEST  
K041165 Follicle Stimulating Hormone (FSH) Endocrinology 06/28/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE  
K040629 Cannabinoids (THC) Toxicology / TDM 05/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE  
K040629 Phencyclidine (PCP) Toxicology / TDM 05/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE  
K040629 Cocaine Metabolites Toxicology / TDM 05/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE  
K040629 Opiates Toxicology / TDM 05/26/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE  
K040629 Methamphetamines Toxicology / TDM 05/26/2004
ACCU-STAT HOME MULTI-DRUG TEST  
K040629 Amphetamines Toxicology / TDM 05/26/2004
APPLIED BIOTECH INSTACHECK FSH TEST  (Professional Use)
K023408 Follicle Stimulating Hormone (FSH) Endocrinology 05/11/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA (THC)  
K040327 Cannabinoids (THC) Toxicology / TDM 04/22/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA (THC) AND COCAINE (COC)  
K040327 Cannabinoids (THC) Toxicology / TDM 04/22/2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA (THC) AND COCAINE (COC)  
K040327 Cocaine Metabolites Toxicology / TDM 04/22/2004
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM  
K040814 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/15/2004
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM  
K040814 Ketone, Blood General Chemistry 04/15/2004
AERSCHER HEMAPROMPT  
K031356 Gastric Occult Blood General Chemistry 04/07/2004
AERSCHER HEMAPROMPT FG  
K972763 Fecal Occult Blood General Chemistry 04/07/2004
ACON ONE STEP OVULATION TEST DEVICE (URINE)  
X030003 Ovulation Test (LH) By Visual Color Comparison Endocrinology 04/05/2004
Acon Helicobacter Pylori Rapid Test Device  
K024350 Helicobacter Pylori Bacteriology 03/23/2004
Apex Biotechnology Corporation {HYPOGUARD ADVANCE INTUITION BLOOD GLUCOSE MONITORING SYSTEM} 
K002621 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/26/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD  
K023712 Cannabinoids (THC) Toxicology / TDM 02/24/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD  
K023712 Phencyclidine (PCP) Toxicology / TDM 02/24/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD  
K023712 Cocaine Metabolites Toxicology / TDM 02/24/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD  
K023712 Opiates Toxicology / TDM 02/24/2004
ADVANTAGE DIAGNOSTICS CORPORATION ADC MULTIPLE DRUG TEST CARD  
K023712 Methamphetamines Toxicology / TDM 02/24/2004
ABBOTT MEDISENSE PRECISION XCEED DIABETES MONITORING SYSTEM  
K033845 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/09/2004
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP  
K033041 Urine hCG By Visual Color Comparison Tests Endocrinology 12/11/2003
ACON ONE STEP OVULATION TEST STRIP (URINE)  
X030004 Ovulation Test (LH) By Visual Color Comparison Endocrinology 11/05/2003
ACON QUIK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)  
K032661 Urine hCG By Visual Color Comparison Tests Endocrinology 11/05/2003
AMERICAN HEALTHCARE EASYGLUCO BLOOD GLUCOSE TEST SYSTEM  
K031501 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/28/2003
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST  
K032510 hCG, Urine Endocrinology 09/15/2003
ACCESS BIO INC. CARESTART HCG COMBO ONE-STEP PREGNANCY TEST  
K031048 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2003
ACCESS BIO INC. CARESTART HCG ONE-STEP PREGNANCY TEST  
K031052 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2003
ACCESS BIO INC. CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST  
K031048 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2003
ACCESS BIO INC. CARESTART PLUS HCG ONE-STEP PREGNANCY TEST  
K031052 Urine hCG By Visual Color Comparison Tests Endocrinology 07/02/2003
APPLIED BIOTECH, INC. RU25 PLUS FSH MENOPAUSE TEST  
K023408 Follicle Stimulating Hormone (FSH) Endocrinology 06/24/2003
AMERISOURCE PHARMACAL ONE-STEP PREGNANCY TEST  
K031271 Urine hCG By Visual Color Comparison Tests Endocrinology 06/23/2003
Acon Strep A Twist Rapid Test  
K023766 Streptococcus, Group A Bacteriology 06/12/2003
ABBOTT MEDISENSE PRECISON XTRA/OPTIUM BLOOD GLUCOSE TEST STRIPS WITH TRUE MEASURE TECHNOLOGY  
K023256 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/23/2003
ALIDEX, INC. POLY STAT SERUM/URINE HCG TEST  
K030430 Urine hCG By Visual Color Comparison Tests Endocrinology 05/01/2003
ADC CLIA WAIVED MARIJUANA (THC) AND COCAINE TEST  
K003708 Cannabinoids (THC) Toxicology / TDM 04/30/2003
ADC CLIA WAIVED MARIJUANA (THC) AND COCAINE TEST  
K003708 Cocaine Metabolites Toxicology / TDM 04/30/2003
ADC CLIA WAIVED MARIJUANA (THC) TEST  
K001567 Cannabinoids (THC) Toxicology / TDM 04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD  
K001126 Cannabinoids (THC) Toxicology / TDM 04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD  
K001126 Phencyclidine (PCP) Toxicology / TDM 04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD  
K001126 Cocaine Metabolites Toxicology / TDM 04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD  
K001126 Opiates Toxicology / TDM 04/29/2003
ADC CLIA WAIVED MULTIPLE DRUG TEST CARD  
K001126 Methamphetamines Toxicology / TDM 04/29/2003
ADVANCED DIAGNOSTICS INC MIDSTREAM PREGNANCY TEST  
K023037 hCG, Urine Endocrinology 04/15/2003
ALATEX SCIENTIFIC PEACE OF MIND MARIJUANA (THC) AND COCAINE HOME DRUG TEST  
K011962 Cannabinoids (THC) Toxicology / TDM 03/17/2003
ALATEX SCIENTIFIC PEACE OF MIND MARIJUANA (THC) AND COCAINE HOME DRUG TEST  
K011962 Cocaine Metabolites Toxicology / TDM 03/17/2003
AERSCHER HEMAPROMPT FG  
K972763 Gastric Occult Blood General Chemistry 02/11/2003
ABBOTT MEDISENSE {PRECISION XTRA COMPLETE} 
K983504 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/10/2003
ABBOTT MEDISENSE {OPTIUM COMPLETE} 
K983504 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/10/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Ketone Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Bilirubin Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Blood Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Glucose Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Leukocytes Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Nitrite Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick pH Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Protein Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/06/2003
ARKRAY, INC., POCKETCHEM UA AUTION STICKS 10TA  
K022386 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/06/2003
APPLIED BIOTECH DRUGFREE @HOME COCAINE TEST  
K022805 Cocaine Metabolites Toxicology / TDM 02/04/2003
APPLIED BIOTECH DRUGFREE @HOME THC TEST  (OTC)
K022802 Cannabinoids (THC) Toxicology / TDM 02/04/2003
APPLIED BIOTECH INSTACHECK OVULATION TEST  (OTC)
K023295 Ovulation Test (LH) By Visual Color Comparison Endocrinology 02/04/2003
APPLIED BIOTECH MENOPAUSE PREDICTOR TEST  
K023408 Follicle Stimulating Hormone (FSH) Endocrinology 02/04/2003
ABBOTT MEDISENSE PRECISION /OPTIMUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS WITH TRUE MEASURE TECHNOLOGY  
K021960 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/13/2003
ADVANTAGE DIAGNOSTICS ADVANTAGE THC TEST  
K001567 Cannabinoids (THC) Toxicology / TDM 12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST  
K001126 Cannabinoids (THC) Toxicology / TDM 12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST  
K001126 Phencyclidine (PCP) Toxicology / TDM 12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST  
K001126 Cocaine Metabolites Toxicology / TDM 12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST  
K001126 Opiates Toxicology / TDM 12/09/2002
ADVANTAGE DIAGNOSTICS MULTI DOA TEST  
K001126 Methamphetamines Toxicology / TDM 12/09/2002
ADVANTAGE DIAGNOSTICS ADVANTAGE THC/COCAINE TEST  
K003708 Cannabinoids (THC) Toxicology / TDM 12/03/2002
ADVANTAGE DIAGNOSTICS ADVANTAGE THC/COCAINE TEST  
K003708 Cocaine Metabolites Toxicology / TDM 12/03/2002
AMEDITECH IMMUTEST HCG PREGNANCY TEST  
K023126 Urine hCG By Visual Color Comparison Tests Endocrinology 11/21/2002
ABBOTT MEDISENSE PCX BLOOD GLUCOSE TESTING SYSTEM  
K022941 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/01/2002
ABBOTT MEDISENSE PCX PLUS BLOOD GLUCOSE TEST STRIPS  
K022941 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/01/2002
ALFA SCIENTIFIC DESIGNS INSTANT-VIEW LH OVULATION PREDICTING TEST  (cassette)
K022829 Ovulation Test (LH) By Visual Color Comparison Endocrinology 11/01/2002
AZOG INC HCG URINE ONE STEP URINE PREGNANCY TEST  (Dipstick)
K022680 Urine hCG By Visual Color Comparison Tests Endocrinology 11/01/2002
AZOG INC HCG URINE ONE STEP URINE PREGNANCY TEST  (cassette)
K022681 Urine hCG By Visual Color Comparison Tests Endocrinology 11/01/2002
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM  
K982076 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/18/2002
ABBOTT MEDISENSE RELION DIABETES CARE STARTER KIT  
K944195 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2002
ALIDEX, INC. POLY STAT HCG DIPSTICK TEST  
K021386 Urine hCG By Visual Color Comparison Tests Endocrinology 08/20/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST  
K013778 Cannabinoids (THC) Toxicology / TDM 02/21/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST  
K013778 Phencyclidine (PCP) Toxicology / TDM 02/21/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST  
K013778 Cocaine Metabolites Toxicology / TDM 02/21/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST  
K013778 Methamphetamines Toxicology / TDM 02/21/2002
ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST  
K013778 Morphine Toxicology / TDM 02/21/2002
AMERITEK DBEST URINARY TRACT INFECTION TEST KIT  
K990873 Urine Dipstick Or Tablet Analytes, Nonautomated Urinalysis 01/03/2002
ACON STREP A RAPID TEST STRIP  
K010582 Streptococcus, Group A Bacteriology 12/18/2001
APEX BIOTECHNOLOGY CORP. GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM  
K011233 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
ACON QUIK-CHECK OVULATION PREDICTOR TEST  
K012252 Ovulation Test (LH) By Visual Color Comparison Endocrinology 08/29/2001
ACON QUIK-CHECK HOME PREGNANCY TEST  
K012215 Urine hCG By Visual Color Comparison Tests Endocrinology 08/23/2001
ADVANTAGE DIAGNOSTICS ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST  
K011962 Cannabinoids (THC) Toxicology / TDM 08/23/2001
ADVANTAGE DIAGNOSTICS ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST  
K011962 Cocaine Metabolites Toxicology / TDM 08/23/2001
ABB0TT SIGNIFY H. PYLORI WHOLE BLOOD  
K990892 Helicobacter Pylori Antibodies General Immunology 07/17/2001
ADVANTAGE DIAGNOSTICS ADVANTAGE THC (MARIJUANA) HOME DRUG TEST  
K010921 Cannabinoids (THC) Toxicology / TDM 07/03/2001
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MONITORING SYSTEM  
K010553 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/22/2001
APEX BIOTECHNOLOGY CORP. GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM  
K002624 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2001
APEX BIOTECHNOLOGY CORP. GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM  
K002621 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2001
ACON ONE STEP PREGNANCY TEST STRIP (URINE)  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 12/19/2000
ACCUNATE-CHOICE  
K992397 Urine hCG By Visual Color Comparison Tests Endocrinology 12/13/2000
AMERITEK DBEST HCG 2 IU/ML TEST KIT  
K001215 Urine hCG By Visual Color Comparison Tests Endocrinology 11/30/2000
ACON HCG URINE/SERUM ONE STEP PREGNANCY TEST DEVICE  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 09/15/2000
ABBOTT MEDISENSE RELION BLOOD GLUCOSE TEST SYSTEM  
K944195 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/14/2000
ABBOTT LABORATORIES, MEDISENSE OPTIUM ADVANCED DIABETES MANAGEMENT SYSTEM  
K983504 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/25/2000
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM  
K983504 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/25/2000
ABBOTT MEDISENSE PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM  
K983504 Ketone, Blood General Chemistry 02/25/2000
AVOCET ACUSURE SYSTEM  (Prescription Home Use)
K994006 Prothrombin Time (PT) Hematology 02/16/2000
AVOCET AVOSURE PT SYSTEM  (Prescription Home Use)
K991286 Prothrombin Time (PT) Hematology 02/16/2000
 
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