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U.S. Department of Health and Human Services

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
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Amphetamines Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Cannabinoids (THC) Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Phencyclidine (PCP) Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Cocaine metabolites Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Methadone Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Propoxyphene Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Methamphetamines Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Benzodiazepines Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Barbiturates Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Morphine Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Tricyclic antidepressants Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Oxycodone Toxicology / TDM 04/11/2014
PTox Drug Screen Cup  (Cassette Dip Card format)
K122633 Buprenorphine Toxicology / TDM 04/11/2014
CR3 Keyless Split Sample Cup Morphine-Oxazepam  (Cup System)
K140089 Benzodiazepines Toxicology / TDM 04/09/2014
CR3 Keyless Split Sample Cup Morphine-Oxazepam  (Cup System)
K140089 Morphine Toxicology / TDM 04/09/2014
Wunder Pregnancy Test  
K130456 hCG, Urine Endocrinology 04/09/2014
Biotech Screening Correction Cup  (Cup format)
K122904 Amphetamines Toxicology / TDM 04/08/2014
Biotech Screening Correction Cup  (Cup format)
K122904 Cannabinoids (THC) Toxicology / TDM 04/08/2014
Biotech Screening Correction Cup  (Cup format)
K122904 Benzodiazepines Toxicology / TDM 04/08/2014
Biotech Screening Correction Cup  (Cup format)
K122904 Barbiturates Toxicology / TDM 04/08/2014
Biotech Screening Correction Cup  (Cup format)
K122904 Oxycodone Toxicology / TDM 04/08/2014
Biotech Screening Correction Cup  
K122904 Phencyclidine (PCP) Toxicology / TDM 04/08/2014
Biotech Screening Correction Cup  
K122904 Cocaine metabolites Toxicology / TDM 04/08/2014
Biotech Screening Correction Cup  
K122904 Methamphetamines Toxicology / TDM 04/08/2014
Biotech Screening Correction Cup  
K122904 Morphine Toxicology / TDM 04/08/2014
Biotech Screening Correction Cup  
K122904 Tricyclic antidepressants Toxicology / TDM 04/08/2014
Biotech Screening Correction Cup  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 04/08/2014
Abaxis Piccolo xpress Chemistry Analyzer  (Capillary-fingerstick)
K130200 Cholesterol General Chemistry 03/21/2014
Abaxis Piccolo xpress Chemistry Analyzer  (Capillary-fingerstick)
K120664 Triglyceride General Chemistry 03/21/2014
Abaxis Piccolo xpress Chemistry Analyzer  (Capillary-fingerstick)
K120662 HDL cholesterol General Chemistry 03/21/2014
Abaxis Piccolo xpress Chemistry Analyzer  (Capillary-fingerstick)
CW140001 Cholesterol General Chemistry 03/21/2014
Abaxis Piccolo xpress Chemistry Analyzer  (Capillary-fingerstick)
CW130006 HDL cholesterol General Chemistry 03/21/2014
Abaxis Piccolo xpress Chemistry Analyzer  (Capillary-fingerstick)
CW130004 Triglyceride General Chemistry 03/21/2014
AimStrip Hb Hemoglobin (Hb) Testing System  
K122553 Hemoglobin Hematology 03/21/2014
Nipro Diagnostics, Inc. TRUE FOCUS Blood Glucose Monitoring System  
K131013 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/21/2014
Nipro Diagnostics, Inc. TRUE FOCUS PRO Blood Glucose Monitoring System  
K131013 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/21/2014
Jant Pharmacal Corp. Accutest (MDMA and OPI) Drug Test Cup {Urine} (Cup format)
K130275 Opiates Toxicology / TDM 03/20/2014
Jant Pharmacal Corp. Accutest (MDMA and OPI) Drug Test Cup {Urine} (Cup format)
K130275 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/20/2014
Courageous CHOICE Pregnancy Test  
K984075 Urine hCG by visual color comparison tests Endocrinology 03/19/2014
Infopia USA, LLC. Healthpro Professional Blood Glucose Monitoring System  
K132862 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/19/2014
Polymed Therapeutics Fastep s10 hcg serum/urine combo test  (test strip)
K132834 hCG, Urine Endocrinology 03/19/2014
Polymed Therapeutics Fastep s10 hcg serum/urine combo test  (cassette)
K132834 hCG, Urine Endocrinology 03/19/2014
Ramco Quick-Trak Combi Test One-Step Pregnancy Test  
K020378 Urine hCG by visual color comparison tests Endocrinology 03/19/2014
Stanbio True 20 Plus One-Step Pregnancy Test  
K020378 Urine hCG by visual color comparison tests Endocrinology 03/19/2014
StanbioQuPID One-Step Pregnancy Test  
K020378 Urine hCG by visual color comparison tests Endocrinology 03/19/2014
StanbioQuPID Plus One-step Pregnancy Test  
K020378 Urine hCG by visual color comparison tests Endocrinology 03/19/2014
BD Veritor System for Rapid Detection of RSV {For use with nasopharyngeal specimens} (Includes a reader)
K132456 Respiratory syncytial virus Virology 03/18/2014
BD Veritor System for Rapid Detection of RSV {For use with nasopharyngeal specimens} (Includes a reader)
CW130005 Respiratory syncytial virus Virology 03/18/2014
Omnis Health Embrace EVO Blood Glucose Monitoring System  
K113208 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/18/2014
RightBio Metrics, RightLevel pH Detector  
X140003 Gastric pH General Chemistry 03/18/2014
RightBio Metrics, RightSpot pH Indicator  
X140003 Gastric pH General Chemistry 03/18/2014
RightBio Metrics, RightSpot Infant pH Indicator  
X140003 Gastric pH General Chemistry 03/18/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Amphetamines Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Cannabinoids (THC) Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Phencyclidine (PCP) Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Cocaine metabolites Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Opiates Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Methadone Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Propoxyphene Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Methamphetamines Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Benzodiazepines Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Barbiturates Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Tricyclic antidepressants Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Oxycodone Toxicology / TDM 03/13/2014
UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
K132812 Buprenorphine Toxicology / TDM 03/13/2014
Apex BioTechnology Corp. AutoSure HT Blood Glucose Monitoring System  
K131750 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/10/2014
MHC Medical Products, LLC. Easy Touch® HealthPro Glucose Monitoring System  
K113192 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/10/2014
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup {Urine} (Cup format)
K130275 Opiates Toxicology / TDM 03/07/2014
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup {Urine} (Cup format)
K130275 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/07/2014
Wondfo Amphetamine Multi-drug Urine Test  (Dip Card format)
K133968 Amphetamines Toxicology / TDM 03/07/2014
Wondfo Amphetamine Multi-drug Urine Test  (Cup format)
K133968 Amphetamines Toxicology / TDM 03/07/2014
Wondfo Buprenorphine Multi-drug Urine Test  (Cup format)
K133968 Buprenorphine Toxicology / TDM 03/07/2014
Wondfo Buprenorphine Multi-drug Urine Test  (Dip Card format)
K133968 Buprenorphine Toxicology / TDM 03/07/2014
Wondfo Cannabinoids Multi-drug Urine Test  (Dip Card format)
K133968 Cannabinoids (THC) Toxicology / TDM 03/07/2014
Wondfo Cannabinoids Multi-drug Urine Test  (Cup format)
K133968 Cannabinoids (THC) Toxicology / TDM 03/07/2014
Wondfo Cocaine Multi-drug Urine Test  (Dip Card format)
K133968 Cocaine metabolites Toxicology / TDM 03/07/2014
Wondfo Cocaine Multi-drug Urine Test  (Cup format)
K133968 Cocaine metabolites Toxicology / TDM 03/07/2014
Wondfo Methadone Multi-drug Urine Test  (Cup format)
K133968 Methadone Toxicology / TDM 03/07/2014
Wondfo Methadone Multi-drug Urine Test  (Dip Card format)
K133968 Methadone Toxicology / TDM 03/07/2014
Wondfo Methamphetamine Multi-drug Urine Test  (Cup format)
K133968 Methamphetamines Toxicology / TDM 03/07/2014
Wondfo Methamphetamine Multi-drug Urine Test  (Dip Card format)
K133968 Methamphetamines Toxicology / TDM 03/07/2014
Wondfo Methylenedioxymethamphetamine Multi-drug Urine Test  (Dip Card format)
K133968 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/07/2014
Wondfo Methylenedioxymethamphetamine Multi-drug Urine Test  (Cup format)
K133968 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/07/2014
Wondfo Morphine Multi-drug Urine Test  (Cup format)
K133968 Morphine Toxicology / TDM 03/07/2014
Wondfo Morphine Multi-drug Urine Test  (Dip Card format)
K133968 Morphine Toxicology / TDM 03/07/2014
Wondfo Nortriptyline Multi-drug Urine Test  (Cup format)
K133968 Tricyclic antidepressants Toxicology / TDM 03/07/2014
Wondfo Nortriptyline Multi-drug Urine Test  (Dip Card format)
K133968 Tricyclic antidepressants Toxicology / TDM 03/07/2014
Wondfo Oxazepam Multi-drug Urine Test  (Dip Card format)
K133968 Benzodiazepines Toxicology / TDM 03/07/2014
Wondfo Oxazepam Multi-drug Urine Test  (Cup format)
K133968 Benzodiazepines Toxicology / TDM 03/07/2014
Wondfo Phencyclidine Multi-drug Urine Test  (Cup format)
K133968 Phencyclidine (PCP) Toxicology / TDM 03/07/2014
Wondfo Phencyclidine Multi-drug Urine Test  (Dip Card format)
K133968 Phencyclidine (PCP) Toxicology / TDM 03/07/2014
Wondfo Secobarbital Multi-drug Urine Test  (Dip Card format)
K133968 Barbiturates Toxicology / TDM 03/07/2014
Wondfo Secobarbital Multi-drug Urine Test  (Cup format)
K133968 Barbiturates Toxicology / TDM 03/07/2014
CERAGEM Medisys Inc. CERA-CHEK 1070 Blood Glucose Monitoring System {Home Use} 
K131727 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/04/2014
Rapid Pathogen Screening, Inc. InflammaDry  
K132066 Matrix metalloproteinases-9 (MMP-9) General Chemistry 02/27/2014
Rapid Pathogen Screening, Inc. InflammaDry  
CW130009 Matrix metalloproteinases-9 (MMP-9) General Chemistry 02/27/2014
Home Aide Diagnostics, Inc., Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M  
K133509 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/21/2014
Progressive Health Supply & Source Corp. Smartest Persona II Blood Glucose Monitoring System Model 6276-S  
K133509 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/21/2014
Progressive Health Supply & Source Corp. Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M  
K133509 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Amphetamines Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Cannabinoids (THC) Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Phencyclidine (PCP) Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Cocaine metabolites Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Opiates Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Methadone Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Propoxyphene Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Methamphetamines Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Benzodiazepines Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Barbiturates Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Morphine Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Tricyclic antidepressants Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Oxycodone Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups  
K130463 Buprenorphine Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Amphetamines Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Cannabinoids (THC) Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Phencyclidine (PCP) Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Cocaine metabolites Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Opiates Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Methadone Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Propoxyphene Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Methamphetamines Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Benzodiazepines Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Barbiturates Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Morphine Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Tricyclic antidepressants Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Oxycodone Toxicology / TDM 02/21/2014
Ultimate Analysis Cup Inc. UA Cups Test Cards  
K130463 Buprenorphine Toxicology / TDM 02/21/2014
EPS Bio Technology Corp EMV3.1 Pro Blood Glucose System  
K133647 Glucose monitoring devices (prescription use only) General Chemistry 02/19/2014
EPS Bio Technology Corp EMV3.1 Self-Monitoring Blood Glucose System  
K133647 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/19/2014
BD Veritor¿ System for Rapid Detection of Group A Strep {direct from throat swab} 
CW130001 Streptococcus, group A Bacteriology 02/18/2014
Clarity HbCheck Hemoglobin Testing System  
K122553 Hemoglobin Hematology 02/18/2014
JANT Accutest Rapid Urease test {H. pylori detection} 
K052708 Helicobacter pylori Bacteriology 02/18/2014
Alfa Scientific Designs, Inc. Confidential Drug Test - Multi Drugs of Abuse Urine Test (OTC)  
K131645 Amphetamines Toxicology / TDM 02/11/2014
Alfa Scientific Designs, Inc. Confidential Drug Test - Multi Drugs of Abuse Urine Test (OTC)  
K131645 Cannabinoids (THC) Toxicology / TDM 02/11/2014
Alfa Scientific Designs, Inc. Confidential Drug Test - Multi Drugs of Abuse Urine Test (OTC)  
K131645 Cocaine metabolites Toxicology / TDM 02/11/2014
Alfa Scientific Designs, Inc. Confidential Drug Test - Multi Drugs of Abuse Urine Test (OTC)  
K131645 Morphine Toxicology / TDM 02/11/2014
Alfa Scientific Designs, Inc. Confidential Drug Test - Multi Drugs of Abuse Urine Test (OTC)  
K131645 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/11/2014
Easy at Home Medical, Areta Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick ketone Urinalysis 02/10/2014
Easy at Home Medical, Areta Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick bilirubin Urinalysis 02/10/2014
Easy at Home Medical, Areta Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick blood Urinalysis 02/10/2014
Easy at Home Medical, Areta Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick glucose Urinalysis 02/10/2014
Easy at Home Medical, Areta Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick leukocytes Urinalysis 02/10/2014
Easy at Home Medical, Areta Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick nitrite Urinalysis 02/10/2014
Easy at Home Medical, Areta Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick Ph Urinalysis 02/10/2014
Easy at Home Medical, Areta Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick protein Urinalysis 02/10/2014
Easy at Home Medical, Areta Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick urobilinogen Urinalysis 02/10/2014
Easy at Home Medical, Areta Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick specific gravity Urinalysis 02/10/2014
Cen-Med Enterprises Elite Plus hCG Pregnancy Serum/Urine Combo Test  
K112101 Urine hCG by visual color comparison tests Endocrinology 01/28/2014
SD BioSensor, Inc. SD GlucoMentor Blood Glucose Monitoring System  
K123517 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/24/2014
SD BioSensor, Inc. SD GlucoMentor Multi Blood Glucose Monitoring System  
K123517 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/24/2014
Acon Laboratories, Inc. On Call Sharp Blood Glucose Monitoring System  
K130284 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/30/2013
Kmart SmartSense Premium Blood Glucose Monitoring System  
K072413 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/24/2013
Kmart SmartSense Value Blood Glucose Monitoring System  
K073573 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/24/2013
On Call Express Blood Glucose Monitoring System  
K132086 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/20/2013
Siemens Microalbustix Reagent Strips (OTC)  
K991315 Urine qualitative dipstick protein Urinalysis 12/16/2013
Siemens Microalbustix Reagent Strips (OTC)  
K991315 Urine qualitative dipstick creatinine Urinalysis 12/16/2013
Sofia Analyzer and Influenza A+B FIA  
CW130003 Influenza A/B Virology 12/13/2013
Sofia Analyzer and Influenza A+B FIA  
K112177 Influenza A/B Virology 12/13/2013
Alere HemoPoint H2 System  
K081719 Hemoglobin Hematology 12/12/2013
Infopia Co., Ltd. GluNEO Lite Blood Glucose Monitoring System  
K132966 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/09/2013
Infopia Co., Ltd. GluNEO Lite Professional Blood Glucose Monitoring System  
K132966 Glucose monitoring devices (prescription use only) General Chemistry 12/09/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665 Amphetamines Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665 Cannabinoids (THC) Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665 Phencyclidine (PCP) Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665 Cocaine metabolites Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665 Opiates Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665 Methamphetamines Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665 Benzodiazepines Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665 Barbiturates Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665 Morphine Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665 Oxycodone Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Cup  
K130665 Buprenorphine Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665 Amphetamines Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665 Cannabinoids (THC) Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665 Phencyclidine (PCP) Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665 Cocaine metabolites Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665 Opiates Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665 Methamphetamines Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665 Benzodiazepines Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665 Barbiturates Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665 Morphine Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665 Oxycodone Toxicology / TDM 12/05/2013
BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
K130665 Buprenorphine Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665 Amphetamines Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665 Cannabinoids (THC) Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665 Phencyclidine (PCP) Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665 Cocaine metabolites Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665 Opiates Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665 Methamphetamines Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665 Benzodiazepines Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665 Barbiturates Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665 Morphine Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665 Oxycodone Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATCup3 One Step Drug Test Cup  
K130665 Buprenorphine Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665 Amphetamines Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665 Cannabinoids (THC) Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665 Phencyclidine (PCP) Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665 Cocaine metabolites Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665 Opiates Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665 Methamphetamines Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665 Benzodiazepines Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665 Barbiturates Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665 Morphine Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665 Oxycodone Toxicology / TDM 12/05/2013
Micro Distributing II, LTD STATDIP One Step Multi-Drug Urine Test Panel  
K130665 Buprenorphine Toxicology / TDM 12/05/2013
Prodigy Choice Blood Glucose Monitoring System  
K122340 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/27/2013
General Life Biotechnology Co., Ltd., BeneCheck Premium GLU Monitoring System  
K123090 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/25/2013
General Life Biotechnology Co., Ltd., BeneCheck Premium PRO GLU Monitoring System  
K123090 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/25/2013
i-SENS, Inc. CareSens N Voice Multi Blood Glucose Monitoring System  
K132288 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/25/2013
Alere iCup Dx Pro Urine Drug Screening Device  
K082898 Amphetamines Toxicology / TDM 11/19/2013
Alere iCup Dx Pro Urine Drug Screening Device  
K082898 Cannabinoids (THC) Toxicology / TDM 11/19/2013
Alere iCup Dx Pro Urine Drug Screening Device  
K082898 Phencyclidine (PCP) Toxicology / TDM 11/19/2013
Alere iCup Dx Pro Urine Drug Screening Device  
K082898 Cocaine metabolites Toxicology / TDM 11/19/2013
Alere iCup Dx Pro Urine Drug Screening Device  
K082898 Opiates Toxicology / TDM 11/19/2013
Alere iCup Dx Pro Urine Drug Screening Device  
K082898 Methadone Toxicology / TDM 11/19/2013
Alere iCup Dx Pro Urine Drug Screening Device  
K082898 Methamphetamines Toxicology / TDM 11/19/2013
Alere iCup Dx Pro Urine Drug Screening Device  
K082898 Benzodiazepines Toxicology / TDM 11/19/2013
Alere iCup Dx Pro Urine Drug Screening Device  
K082898 Barbiturates Toxicology / TDM 11/19/2013
Alere iCup Dx Pro Urine Drug Screening Device  
K082898 Tricyclic antidepressants Toxicology / TDM 11/19/2013
Alere iCup Dx Pro Urine Drug Screening Device  
K082898 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/19/2013
Alere iCup Dx Pro Urine Drug Screening Device  
K082898 Oxycodone Toxicology / TDM 11/19/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665 Amphetamines Toxicology / TDM 11/19/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665 Cannabinoids (THC) Toxicology / TDM 11/19/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665 Phencyclidine (PCP) Toxicology / TDM 11/19/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665 Cocaine metabolites Toxicology / TDM 11/19/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665 Opiates Toxicology / TDM 11/19/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665 Methamphetamines Toxicology / TDM 11/19/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665 Benzodiazepines Toxicology / TDM 11/19/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665 Barbiturates Toxicology / TDM 11/19/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665 Morphine Toxicology / TDM 11/19/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/19/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665 Oxycodone Toxicology / TDM 11/19/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  (Cup format)
K130665 Buprenorphine Toxicology / TDM 11/19/2013
Co-innovation Biotech Co., Ltd. One step hcg test cassette  
K132085 hCG, Urine Endocrinology 11/13/2013
Co-innovation Biotech Co., Ltd. One step hcg test midstream  
K132085 hCG, Urine Endocrinology 11/13/2013
Co-innovation Biotech Co., Ltd. One step hcg test strip  
K132085 hCG, Urine Endocrinology 11/13/2013
Jant Pharmacal Corp, LipidPlus Professional Lipid Profile and Glucose Measuring System  
K130295 Glucose monitoring devices (prescription use only) General Chemistry 11/12/2013
Jant Pharmacal Corp, LipidPlus Professional Lipid Profile and Glucose Measuring System {LipidPlus Lipid Profile test strips} 
K130295 Triglyceride General Chemistry 11/12/2013
Jant Pharmacal Corp, LipidPlus Professional Lipid Profile and Glucose Measuring System {LipidPlus Lipid Profile test strips} 
K130295 HDL cholesterol General Chemistry 11/12/2013
Jant Pharmacal Corp, LipidPlus Professional Lipid Profile and Glucose Measuring System {LipidPlus Lipid Profile test strips} 
K130295 Cholesterol General Chemistry 11/12/2013
LifeScan OneTouch Ultra Blood Glucose Meter {UniStrip LLC UniStrip1 Test Strips} 
K113135 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/07/2013
LifeScan OneTouch Ultra2 Blood Glucose Meter {UniStrip LLC UniStrip1 Test Strips} 
K113135 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/07/2013
LifeScan OneTouch UltraMini Blood Glucose Meter {UniStrip LLC UniStrip1 Test Strips} 
K113135 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/07/2013
LifesScan OneTouch UltrasSmart Blood Glucose Monitoring System {UniStrip LLC UniStrip1 Test Strips} 
K113135 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/07/2013
UCP Biosciences Inc. Home Pregnancy Cassette Test  
K131236 hCG, Urine Endocrinology 11/07/2013
UCP Biosciences Inc. Home Pregnancy Dip/Card Strip  
K131236 hCG, Urine Endocrinology 11/07/2013
UCP Biosciences Inc. Home Pregnancy Midstream Test  
K131236 hCG, Urine Endocrinology 11/07/2013
Prodigy Diabetes Care, LLC Prodigy Preferred Blood Glucose Monitoring System  
K122338 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/06/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Card  
K130665 Amphetamines Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Card  
K130665 Cannabinoids (THC) Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Card  
K130665 Phencyclidine (PCP) Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Card  
K130665 Cocaine metabolites Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Card  
K130665 Opiates Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Card  
K130665 Methamphetamines Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Card  
K130665 Benzodiazepines Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Card  
K130665 Barbiturates Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Card  
K130665 Morphine Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Card  
K130665 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Card  
K130665 Oxycodone Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Card  
K130665 Buprenorphine Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Cup  
K130665 Amphetamines Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Cup  
K130665 Cannabinoids (THC) Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Cup  
K130665 Phencyclidine (PCP) Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Cup  
K130665 Cocaine metabolites Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Cup  
K130665 Opiates Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Cup  
K130665 Methamphetamines Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Cup  
K130665 Benzodiazepines Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Cup  
K130665 Barbiturates Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Cup  
K130665 Morphine Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Cup  
K130665 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Cup  
K130665 Oxycodone Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc, AIT Laboratories Drug of Abuse Cup  
K130665 Buprenorphine Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card  
K122904 Amphetamines Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card  
K122904 Cannabinoids (THC) Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card  
K122904 Phencyclidine (PCP) Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card  
K122904 Cocaine metabolites Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card  
K122904 Methadone Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card  
K122904 Methamphetamines Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card  
K122904 Benzodiazepines Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card  
K122904 Barbiturates Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card  
K122904 Morphine Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card  
K122904 Tricyclic antidepressants Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Card  
K122904 Oxycodone Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup  
K122904 Amphetamines Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup  
K122904 Cannabinoids (THC) Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup  
K122904 Phencyclidine (PCP) Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup  
K122904 Cocaine metabolites Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup  
K122904 Methadone Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup  
K122904 Methamphetamines Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup  
K122904 Benzodiazepines Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup  
K122904 Barbiturates Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup  
K122904 Morphine Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup  
K122904 Tricyclic antidepressants Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 10/24/2013
American Institute of Toxicology, Inc., AIT Laboratories Drug of Abuse Cup  
K122904 Oxycodone Toxicology / TDM 10/24/2013
Medimpex Q Test Buprenorphine Drug Cup Test  
K122064 Opiates Toxicology / TDM 10/24/2013
Omnis Health Embrace Pro Blood Glucose Monitoring System  
K083628 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/24/2013
Roche Diagnostics Accu-Chek Aviva Expert Blood Glucose Monitoring System  
K131366 Glucose monitoring devices (prescription use only) General Chemistry 10/22/2013
Fora Care Inc, TD-4268 Blood Glucose Monitoring System  
K120042 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/21/2013
Fora Care Inc, TD-4268 Multi Blood Glucose Monitoring System  
K120042 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/21/2013
AgaMatrix CareOne Value Blood Glucose Monitoring System  
K073573 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/18/2013
Nova Biomedical FOCUS Blood Glucose Monitoring System  
K131013 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/18/2013
Nova Biomedical FOCUS PRO Blood Glucose Monitoring System  
K131013 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/18/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Cup  
K131645 Amphetamines Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Cup  
K131645 Cannabinoids (THC) Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Cup  
K131645 Phencyclidine (PCP) Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Cup  
K131645 Cocaine metabolites Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Cup  
K131645 Opiates Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Cup  
K131645 Methadone Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Cup  
K131645 Methamphetamines Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Cup  
K131645 Benzodiazepines Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Cup  
K131645 Barbiturates Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Cup  
K131645 Morphine Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Cup  
K131645 Tricyclic antidepressants Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Cup  
K131645 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Panel  
K131645 Amphetamines Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Panel  
K131645 Cannabinoids (THC) Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Panel  
K131645 Phencyclidine (PCP) Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Panel  
K131645 Cocaine metabolites Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Panel  
K131645 Opiates Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Panel  
K131645 Methadone Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Panel  
K131645 Methamphetamines Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Panel  
K131645 Benzodiazepines Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Panel  
K131645 Barbiturates Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Panel  
K131645 Morphine Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Panel  
K131645 Tricyclic antidepressants Toxicology / TDM 10/09/2013
Alfa Scientific Designs, Inc. Instant-View Multi-Drug of Abuse Urine Test Panel  
K131645 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 10/09/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K130665 Opiates Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K130665 Buprenorphine Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K122904 Amphetamines Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K122904 Cannabinoids (THC) Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K122904 Phencyclidine (PCP) Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K122904 Cocaine metabolites Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K122904 Methadone Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K122904 Methamphetamines Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K122904 Benzodiazepines Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K122904 Barbiturates Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K122904 Morphine Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K122904 Tricyclic antidepressants Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR2 Multi-Drug Urine Test Cup  
K122904 Oxycodone Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K122904 Amphetamines Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K122904 Cannabinoids (THC) Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K122904 Phencyclidine (PCP) Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K122904 Cocaine metabolites Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K122904 Methadone Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K122904 Methamphetamines Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K122904 Benzodiazepines Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K122904 Barbiturates Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K122904 Morphine Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K122904 Tricyclic antidepressants Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K122904 Oxycodone Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K130665 Opiates Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
K130665 Buprenorphine Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K130665 Opiates Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K130665 Buprenorphine Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K122904 Amphetamines Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K122904 Cannabinoids (THC) Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K122904 Phencyclidine (PCP) Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K122904 Cocaine metabolites Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K122904 Methadone Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K122904 Methamphetamines Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K122904 Benzodiazepines Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K122904 Barbiturates Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K122904 Morphine Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K122904 Tricyclic antidepressants Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U2 Multi-Drug Urine Test Cup  
K122904 Oxycodone Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K122904 Amphetamines Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K122904 Cannabinoids (THC) Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K122904 Phencyclidine (PCP) Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K122904 Cocaine metabolites Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K122904 Methadone Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K122904 Methamphetamines Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K122904 Benzodiazepines Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K122904 Barbiturates Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K122904 Morphine Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K122904 Tricyclic antidepressants Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K122904 Oxycodone Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K130665 Opiates Toxicology / TDM 10/04/2013
uVera Diagnostics, Inc. SMARTOX U3 Multi-Drug Urine Test Cup  
K130665 Buprenorphine Toxicology / TDM 10/04/2013
Syntron Bioresearch Inc, QuikScreen Multi MDMA Drug Cup Test {Urine} (Cup format)
K130275 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/27/2013
Syntron Bioresearch Inc, QuikScreen Multi OPiate Drug Cup Test {Urine} (Cup format)
K130275 Opiates Toxicology / TDM 09/27/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Amphetamines Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Cannabinoids (THC) Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Phencyclidine (PCP) Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Cocaine metabolites Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Opiates Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Methadone Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Propoxyphene Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Methamphetamines Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Benzodiazepines Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Barbiturates Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Morphine Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Tricyclic antidepressants Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Oxycodone Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Drug Test Cards  
K131811 Buprenorphine Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Amphetamines Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Cannabinoids (THC) Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Phencyclidine (PCP) Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Cocaine metabolites Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Opiates Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Methadone Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Propoxyphene Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Methamphetamines Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Benzodiazepines Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Barbiturates Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Morphine Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Tricyclic antidepressants Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Oxycodone Toxicology / TDM 09/25/2013
American Screening Corporation, Inc. Discover Multi-Panel Drug Test Cups  
K131811 Buprenorphine Toxicology / TDM 09/25/2013
AgaMatrix CareOne Premium Blood Glucose Monitoring System  
K072413 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013
Fora Care Fora Diamond Mini Blood Glucose Monitoring System   
K111890 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013
Fora Care Fora Diamond Prima Blood Glucose Monitoring System   
K111890 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013
FORA CARE TD-4239 BLOOD GLUCOSE MONITORING SYSTEM  
K101635 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013
FORA CARE TD-4239 multi BLOOD GLUCOSE MONITORING SYSTEM  
K101635 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013
Gluco Perfect L.L.C., Perfect 3 Blood Glucose Monitoring System Model 6267-S  
K122525 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013
Gluco Perfect L.L.C., Perfect 3 Multi Blood Glucose Monitoring System Model 6267-M  
K122525 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/12/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Amphetamines Toxicology / TDM 09/10/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Cannabinoids (THC) Toxicology / TDM 09/10/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Phencyclidine (PCP) Toxicology / TDM 09/10/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Cocaine metabolites Toxicology / TDM 09/10/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Opiates Toxicology / TDM 09/10/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Methadone Toxicology / TDM 09/10/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Methamphetamines Toxicology / TDM 09/10/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Benzodiazepines Toxicology / TDM 09/10/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Barbiturates Toxicology / TDM 09/10/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Tricyclic antidepressants Toxicology / TDM 09/10/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/10/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Oxycodone Toxicology / TDM 09/10/2013
Alere iScreen DX Single Dip Card  (The Alere iScreen DX Single Dip Card may include a maximum of four drugs in any combination of the 13 claimed drugs.)
K030113 Buprenorphine Toxicology / TDM 09/10/2013
Clarity MONO Mononucleosis Rapid Test Device (whole blood)  
K042272 Infectious mononucleosis antibodies (mono) General Immunology 09/10/2013
DE HEALTHCARE PRODUCTS TRUVIEW MONO TEST  
K973559 Infectious mononucleosis antibodies (mono) General Immunology 09/10/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Cup  
K122904 Amphetamines Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Cup  
K122904 Cannabinoids (THC) Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Cup  
K122904 Phencyclidine (PCP) Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Cup  
K122904 Cocaine metabolites Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Cup  
K122904 Methadone Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Cup  
K122904 Methamphetamines Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Cup  
K122904 Benzodiazepines Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Cup  
K122904 Barbiturates Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Cup  
K122904 Morphine Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Cup  
K122904 Tricyclic antidepressants Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Cup  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Cup  
K122904 Oxycodone Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Panel  
K122904 Amphetamines Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Panel  
K122904 Cannabinoids (THC) Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Panel  
K122904 Phencyclidine (PCP) Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Panel  
K122904 Cocaine metabolites Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Panel  
K122904 Methadone Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Panel  
K122904 Methamphetamines Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Panel  
K122904 Benzodiazepines Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Panel  
K122904 Barbiturates Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Panel  
K122904 Morphine Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Panel  
K122904 Tricyclic antidepressants Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Panel  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/06/2013
BTNX Inc. Rapid Response Multi-Drug Urine Test Panel  
K122904 Oxycodone Toxicology / TDM 09/06/2013
Medline Pregnancy Combo Test (Cassette)  
K984077 Urine hCG by visual color comparison tests Endocrinology 08/28/2013
DELBio Incorporation DiaTrue Plus Blood Glucose Monitoring System  
K130244 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/27/2013
Jant Pharmacal Corporation Accutest Buprenorphine Drug Test Cup  
K122064 Opiates Toxicology / TDM 08/27/2013
DolgenCorp Rexall Blood Glucose Monitoring System  
K073573 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/26/2013
Alere HemoPoint H2 Hemoglobin System  
K081719 Hemoglobin Hematology 08/22/2013
DELBio DiaTrue Plus Blood Glucose Monitoring System  
K103329 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
Diabetes Care Club, Rightest GM250S Blood Glucose Monitoring System  
K092052 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
Hygieia, Inc. BaseSens I Blood Glucose Monitoring System  
K093475 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
I-Sens, Inc. ACURA PLUS Multi Blood Glucose Monitoring System  
K131419 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
i-SENS, Inc. CareSens N LINK Blood Glucose Monitoring System  
K130696 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
i-SENS, Inc. CareSens N LINK Multi Blood Glucose Monitoring System  
K130696 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
Medimpex United Inc. QTEST hCG Pregnancy Serum/Urine Combo Test  
K112101 Urine hCG by visual color comparison tests Endocrinology 08/22/2013
Medline Fecal Occult Blood Test  (cassette)
K070660 Fecal occult blood General Chemistry 08/22/2013
Tyson Bioresearch, Inc., Guardian TB100 Blood Glucose Monitoring System  
K073492 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
Visgeneer, Inc. eBchek Blood Glucose Monitoring System  
K122181 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/22/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Cannabinoids (THC) Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Phencyclidine (PCP) Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Cocaine metabolites Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Opiates Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Methadone Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Propoxyphene Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Methamphetamines Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Benzodiazepines Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Barbiturates Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Morphine Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Tricyclic antidepressants Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Oxycodone Toxicology / TDM 08/15/2013
American Screening Corporation One Screen Drug Test Cards  
K130463 Buprenorphine Toxicology / TDM 08/15/2013
American Screening Corporation Reveal Multi-Drug Testing Cups  
K130463 Propoxyphene Toxicology / TDM 08/15/2013
American Screening Corporation Reveal Multi-Drug Testing Cups  
K130463 Buprenorphine Toxicology / TDM 08/15/2013
UCP Biosciences, Inc. Multiple Drug Screen Cups  
K130463 Propoxyphene Toxicology / TDM 08/15/2013
UCP Biosciences, Inc. Multiple Drug Screen Cups  
K130463 Buprenorphine Toxicology / TDM 08/15/2013
APC Workforce Solutions ZeroChaos Multi Panel Drug Cup Screen  (Professional Use)
K071489 Amphetamines Toxicology / TDM 08/05/2013
APC Workforce Solutions ZeroChaos Multi Panel Drug Cup Screen  (Professional Use)
K071489 Cannabinoids (THC) Toxicology / TDM 08/05/2013
APC Workforce Solutions ZeroChaos Multi Panel Drug Cup Screen  (Professional Use)
K071489 Phencyclidine (PCP) Toxicology / TDM 08/05/2013
APC Workforce Solutions ZeroChaos Multi Panel Drug Cup Screen  (Professional Use)
K071489 Cocaine metabolites Toxicology / TDM 08/05/2013
APC Workforce Solutions ZeroChaos Multi Panel Drug Cup Screen  (Professional Use)
K071489 Methadone Toxicology / TDM 08/05/2013
APC Workforce Solutions ZeroChaos Multi Panel Drug Cup Screen  (Professional Use)
K071489 Methamphetamines Toxicology / TDM 08/05/2013
APC Workforce Solutions ZeroChaos Multi Panel Drug Cup Screen  (Professional Use)
K071489 Benzodiazepines Toxicology / TDM 08/05/2013
APC Workforce Solutions ZeroChaos Multi Panel Drug Cup Screen  (Professional Use)
K071489 Barbiturates Toxicology / TDM 08/05/2013
APC Workforce Solutions ZeroChaos Multi Panel Drug Cup Screen  (Professional Use)
K071489 Morphine Toxicology / TDM 08/05/2013
APC Workforce Solutions ZeroChaos Multi Panel Drug Cup Screen  (Professional Use)
K071489 Tricyclic antidepressants Toxicology / TDM 08/05/2013
APC Workforce Solutions ZeroChaos Multi Panel Drug Cup Screen  (Professional Use)
K071489 Oxycodone Toxicology / TDM 08/05/2013
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489 Amphetamines Toxicology / TDM 08/05/2013
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489 Cannabinoids (THC) Toxicology / TDM 08/05/2013
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489 Phencyclidine (PCP) Toxicology / TDM 08/05/2013
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489 Cocaine metabolites Toxicology / TDM 08/05/2013
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489 Methadone Toxicology / TDM 08/05/2013
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489 Methamphetamines Toxicology / TDM 08/05/2013
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489 Benzodiazepines Toxicology / TDM 08/05/2013
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489 Barbiturates Toxicology / TDM 08/05/2013
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489 Morphine Toxicology / TDM 08/05/2013
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489 Tricyclic antidepressants Toxicology / TDM 08/05/2013
Devon Medical Products CentralCheck Multiple Drug Cup Test  (Professional Use)
K071489 Oxycodone Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489 Amphetamines Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489 Cannabinoids (THC) Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489 Phencyclidine (PCP) Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489 Cocaine metabolites Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489 Methadone Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489 Methamphetamines Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489 Benzodiazepines Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489 Barbiturates Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489 Morphine Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489 Tricyclic antidepressants Toxicology / TDM 08/05/2013
Jant Pharmacal Corp. Accutest Drug Test Cup  (Professional Use)
K071489 Oxycodone Toxicology / TDM 08/05/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Amphetamines Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Cannabinoids (THC) Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Phencyclidine (PCP) Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Cocaine metabolites Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Opiates Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Methadone Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Methamphetamines Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Benzodiazepines Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Barbiturates Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Tricyclic antidepressants Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Oxycodone Toxicology / TDM 08/01/2013
Alere iScreen DX Multi-Drugs of Abuse Dip Test  
K022355 Buprenorphine Toxicology / TDM 08/01/2013
Infopia Co., Ltd. GluNEO Blood Glucose Monitoring System {Home Use} 
K130181 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/01/2013
Infopia Co., Ltd. GluNEO Professional Blood Glucose Monitoring System {Professional Use} 
K130181 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/01/2013
Medimpex United, Inc. QTEST At-Home Pregnancy Test  
K122907 Urine hCG by visual color comparison tests Endocrinology 08/01/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Amphetamines Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Cannabinoids (THC) Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Phencyclidine (PCP) Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Cocaine metabolites Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Methadone Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Propoxyphene Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Methamphetamines Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Benzodiazepines Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Barbiturates Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Morphine Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Tricyclic antidepressants Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Oxycodone Toxicology / TDM 07/29/2013
Alere iCup Dx 14  (Cassette Dip Card format)
K122633 Buprenorphine Toxicology / TDM 07/29/2013
Chemtron Biotech, Inc., Chemtrue hCG Pregnancy Urine Midstream Test  
K131931 Urine hCG by visual color comparison tests Endocrinology 07/29/2013
Poly stat Strep A Flip Test  
K040708 Streptococcus, group A Bacteriology 07/29/2013
SCI International/Saless Enterprise NEW CHOICE At HOME PREGNANCY (hCG) Test Cassette  
K012215 Urine hCG by visual color comparison tests Endocrinology 07/29/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545 Amphetamines Toxicology / TDM 07/19/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545 Cannabinoids (THC) Toxicology / TDM 07/19/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545 Phencyclidine (PCP) Toxicology / TDM 07/19/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545 Cocaine metabolites Toxicology / TDM 07/19/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545 Methadone Toxicology / TDM 07/19/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545 Methamphetamines Toxicology / TDM 07/19/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545 Benzodiazepines Toxicology / TDM 07/19/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545 Barbiturates Toxicology / TDM 07/19/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545 Morphine Toxicology / TDM 07/19/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545 Tricyclic antidepressants Toxicology / TDM 07/19/2013
Confirm Biosciences RELI ON Multi-Drug of Abuse Urine Cup Test  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/19/2013
Confirm Biosciences ReliOn Urine Screening Test  
K063545 Cannabinoids (THC) Toxicology / TDM 07/19/2013
Confirm Biosciences ReliOn Urine Screening Test  
K063545 Cocaine metabolites Toxicology / TDM 07/19/2013
Confirm Biosciences ReliOn Urine Screening Test  
K063545 Methamphetamines Toxicology / TDM 07/19/2013
Confirm Biosciences ReliOn Urine Screening Test  
K063545 Morphine Toxicology / TDM 07/19/2013
Major Biosystem Corp. AP-2000 Blood Glucose Monitoring System  
K103116 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/19/2013
Major Biosystem Corp. AP-2000multi Blood Glucose Monitoring System  
K103116 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/19/2013
Major Biosystem Corp. AP-2010 Blood Glucose Monitoring System  
K103116 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/19/2013
Major Biosystem Corp. AP-2010multi Blood Glucose Monitoring System  
K103116 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/19/2013
Major Biosystem Corp. AP-2020 Blood Glucose Monitoring System  
K103116 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/19/2013
Major Biosystem Corp. AP-2020multi Blood Glucose Monitoring System  
K103116 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/19/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K131811 Propoxyphene Toxicology / TDM 07/19/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K131811 Buprenorphine Toxicology / TDM 07/19/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K131811 Propoxyphene Toxicology / TDM 07/19/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K131811 Buprenorphine Toxicology / TDM 07/19/2013
Bayer Contour Next USB Blood Glucose Monitoring System  
K121087 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/12/2013
BTNX Inc. Rapid Response FSH Menopausal Test  
K052662 Follicle stimulating hormone (FSH) Endocrinology 07/12/2013
Fora Care, Foracare GD20 Blood Glucose Monitoring System  
K124040 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/12/2013
Global Quality Health Inc. UT-Fem For Women UTI Test Strips  
K063295 Nitrite, urine General Chemistry 07/12/2013
Global Quality Health Inc. UT-Fem For Women UTI Test Strips  
K063295 Leukocyte esterase, urinary Urinalysis 07/12/2013
OPTUMRx Blood Glucose Monitoring System  
K090057 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/12/2013
Express Diagnostics Int'l Inc. DrugCheck Waive TC Multiple Drug Cup Test  
K071489 Tricyclic antidepressants Toxicology / TDM 07/03/2013
Express Diagnostics Int'l Inc. DrugCheck Waive TC Multiple Drug Cup Test  (Professional Use)
K071489 Amphetamines Toxicology / TDM 07/03/2013
Express Diagnostics Int'l Inc. DrugCheck Waive TC Multiple Drug Cup Test  (Professional Use)
K071489 Cannabinoids (THC) Toxicology / TDM 07/03/2013
Express Diagnostics Int'l Inc. DrugCheck Waive TC Multiple Drug Cup Test  (Professional Use)
K071489 Phencyclidine (PCP) Toxicology / TDM 07/03/2013
Express Diagnostics Int'l Inc. DrugCheck Waive TC Multiple Drug Cup Test  (Professional Use)
K071489 Cocaine metabolites Toxicology / TDM 07/03/2013
Express Diagnostics Int'l Inc. DrugCheck Waive TC Multiple Drug Cup Test  (Professional Use)
K071489 Methadone Toxicology / TDM 07/03/2013
Express Diagnostics Int'l Inc. DrugCheck Waive TC Multiple Drug Cup Test  (Professional Use)
K071489 Methamphetamines Toxicology / TDM 07/03/2013
Express Diagnostics Int'l Inc. DrugCheck Waive TC Multiple Drug Cup Test  (Professional Use)
K071489 Benzodiazepines Toxicology / TDM 07/03/2013
Express Diagnostics Int'l Inc. DrugCheck Waive TC Multiple Drug Cup Test  (Professional Use)
K071489 Barbiturates Toxicology / TDM 07/03/2013
Express Diagnostics Int'l Inc. DrugCheck Waive TC Multiple Drug Cup Test  (Professional Use)
K071489 Morphine Toxicology / TDM 07/03/2013
Express Diagnostics Int'l Inc. DrugCheck Waive TC Multiple Drug Cup Test  (Professional Use)
K071489 Oxycodone Toxicology / TDM 07/03/2013
Henry Schein OneStep Pro+ Strep A Cassette  
K040708 Streptococcus, group A Bacteriology 07/03/2013
Abbott Freestyle precision pro blood glucose and beta-ketone monitoring system  
K130094 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/01/2013
Abbott Freestyle precision pro blood glucose and beta-ketone monitoring system  
K130094 Ketone, blood General Chemistry 07/01/2013
BioSence Medical Devices, Solus I Audible Blood Glucose Management System  
K093764 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/01/2013
INFOPIA USA, LipidPro® Professional Lipid Profile and Glucose Measuring System {LipidPro Lipid Profile test strips} 
K130295 Triglyceride General Chemistry 07/01/2013
INFOPIA USA, LipidPro® Professional Lipid Profile and Glucose Measuring System {LipidPro Lipid Profile test strips} 
K130295 HDL cholesterol General Chemistry 07/01/2013
INFOPIA USA, LipidPro® Professional Lipid Profile and Glucose Measuring System {LipidPro Lipid Profile test strips} 
K130295 Cholesterol General Chemistry 07/01/2013
INFOPIA USA, LipidPro® Professional Lipid Profile and Glucose Measuring System  
K130295 Triglyceride General Chemistry 07/01/2013
INFOPIA USA, LipidPro® Professional Lipid Profile and Glucose Measuring System  
K130295 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/01/2013
INFOPIA USA, LipidPro® Professional Lipid Profile and Glucose Measuring System  
K130295 HDL cholesterol General Chemistry 07/01/2013
INFOPIA USA, LipidPro® Professional Lipid Profile and Glucose Measuring System  
K130295 Cholesterol General Chemistry 07/01/2013
Advin Multi-Drug Screen Test  
K122809 Amphetamines Toxicology / TDM 06/24/2013
Advin Multi-Drug Screen Test  
K122809 Cannabinoids (THC) Toxicology / TDM 06/24/2013
Advin Multi-Drug Screen Test  
K122809 Phencyclidine (PCP) Toxicology / TDM 06/24/2013
Advin Multi-Drug Screen Test  
K122809 Cocaine metabolites Toxicology / TDM 06/24/2013
Advin Multi-Drug Screen Test  
K122809 Opiates Toxicology / TDM 06/24/2013
Advin Multi-Drug Screen Test  
K122809 Methadone Toxicology / TDM 06/24/2013
Advin Multi-Drug Screen Test  
K122809 Methamphetamines Toxicology / TDM 06/24/2013
Advin Multi-Drug Screen Test  
K122809 Benzodiazepines Toxicology / TDM 06/24/2013
Advin Multi-Drug Screen Test  
K122809 Barbiturates Toxicology / TDM 06/24/2013
Advin Multi-Drug Screen Test  
K122809 Morphine Toxicology / TDM 06/24/2013
Advin Multi-Drug Screen Test  
K122809 Tricyclic antidepressants Toxicology / TDM 06/24/2013
Advin Multi-Drug Screen Test  
K122809 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/24/2013
Advin Multi-Drug Screen Test  
K122809 Oxycodone Toxicology / TDM 06/24/2013
Medline Industries Inc. Medline Pregnancy Urine Test (Cassette)  
K984076 Urine hCG by visual color comparison tests Endocrinology 06/24/2013
Medline Industries Inc. Medline Pregnancy Urine Test (Dip-Strip)  
K984079 Urine hCG by visual color comparison tests Endocrinology 06/24/2013
MicoBioMed Co Ltd, Veri-Q Plus MGD-1001 Blood Glucose Monitoring System  
K123007 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/24/2013
MicoBioMed Co Ltd, Veri-Q self-testing MGD-1001 Blood Glucose Monitoring System  
K123007 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/24/2013
MiCoBioMed Veri-Q plus MGD-2001 Blood Glucose Monitoring System  
K123016 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/24/2013
MiCoBioMed Veri-Q self-testing MGD-2001 Blood Glucose Monitoring System  
K123016 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/24/2013
TysonBio AC500 Blood Glucose Monitoring System  
K123087 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/24/2013
TysonBio AC500 Pro Blood Glucose Monitoring System  
K123087 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/24/2013
TysonBio AC800 Blood Glucose Monitoring System  
K123087 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/24/2013
TysonBio AC800 Pro Blood Glucose Monitoring System  
K123087 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/24/2013
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup Buprenorphine  
K122064 Opiates Toxicology / TDM 06/18/2013
Syntron Bioresearch Inc QuikScreen Buprenorphine Drug CupTest  
K122064 Opiates Toxicology / TDM 06/18/2013
Carmel Diagnostic, LLC, F.Y.I. One-Step Urine Pregnancy Test  
K980531 Urine hCG by visual color comparison tests Endocrinology 06/05/2013
Wunder Test, Home Drug Screen (Marijuana)  
K102428 Cannabinoids (THC) Toxicology / TDM 06/04/2013
Chemtrue® hCG Combo (Serum/Urine) Cassette Test  
K123844 hCG, Urine Endocrinology 05/30/2013
Chemtrue® hCG Pregnancy Urine Cassette Test  
K123844 hCG, Urine Endocrinology 05/30/2013
Chemtrue® hCG Pregnancy Urine Dipstick  
K123844 hCG, Urine Endocrinology 05/30/2013
Alere iScreen DX Single Dip Card  
K022355 Amphetamines Toxicology / TDM 05/29/2013
Alere iScreen DX Single Dip Card  
K022355 Cannabinoids (THC) Toxicology / TDM 05/29/2013
Alere iScreen DX Single Dip Card  
K022355 Phencyclidine (PCP) Toxicology / TDM 05/29/2013
Alere iScreen DX Single Dip Card  
K022355 Cocaine metabolites Toxicology / TDM 05/29/2013
Alere iScreen DX Single Dip Card  
K022355 Opiates Toxicology / TDM 05/29/2013
Alere iScreen DX Single Dip Card  
K022355 Methadone Toxicology / TDM 05/29/2013
Alere iScreen DX Single Dip Card  
K022355 Methamphetamines Toxicology / TDM 05/29/2013
Alere iScreen DX Single Dip Card  
K022355 Benzodiazepines Toxicology / TDM 05/29/2013
Alere iScreen DX Single Dip Card  
K022355 Barbiturates Toxicology / TDM 05/29/2013
Alere iScreen DX Single Dip Card  
K022355 Tricyclic antidepressants Toxicology / TDM 05/29/2013
Alere iScreen DX Single Dip Card  
K022355 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/29/2013
Alere iScreen DX Single Dip Card  
K022355 Buprenorphine Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K122904 Amphetamines Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K122904 Cannabinoids (THC) Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K122904 Phencyclidine (PCP) Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K122904 Cocaine metabolites Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K122904 Methadone Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K122904 Methamphetamines Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K122904 Barbiturates Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K122904 Benzodiazepines Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K122904 Morphine Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K122904 Tricyclic antidepressants Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K122904 Oxycodone Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K130665 Opiates Toxicology / TDM 05/29/2013
Cliawaived Inc. Drug of Abuse Card  
K130665 Buprenorphine Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K130665 Opiates Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K130665 Buprenorphine Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K122904 Amphetamines Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K122904 Cannabinoids (THC) Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K122904 Phencyclidine (PCP) Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K122904 Cocaine metabolites Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K122904 Methadone Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K122904 Methamphetamines Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K122904 Benzodiazepines Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K122904 Barbiturates Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K122904 Morphine Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K122904 Tricyclic antidepressants Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/29/2013
Cliawaived Inc. Instant Drug Test Cup  
K122904 Oxycodone Toxicology / TDM 05/29/2013
Hemosense INRatio Prothrombin Time (PT) Monitoring System  (Prescription Home Use)
K021923 Prothrombin time (PT) Hematology 05/29/2013
SCI International Inc. New Choice At Home Drug Test: Marijuana (Strip Format)  
K121231 Cannabinoids (THC) Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665 Amphetamines Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665 Cannabinoids (THC) Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665 Phencyclidine (PCP) Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665 Cocaine metabolites Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665 Opiates Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665 Methamphetamines Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665 Benzodiazepines Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665 Barbiturates Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665 Morphine Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665 Oxycodone Toxicology / TDM 05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup  
K130665 Buprenorphine Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665 Amphetamines Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665 Cannabinoids (THC) Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665 Phencyclidine (PCP) Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665 Cocaine metabolites Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665 Opiates Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665 Methamphetamines Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665 Benzodiazepines Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665 Barbiturates Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665 Morphine Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665 Oxycodone Toxicology / TDM 05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card  
K130665 Buprenorphine Toxicology / TDM 05/29/2013
Alere Toxicology Services, Inc. Tox Screen Drugs of Abuse Test Cup  (Professional Use)
K050878 Amphetamines Toxicology / TDM 05/17/2013
Alere Toxicology Services, Inc. Tox Screen Drugs of Abuse Test Cup  (Professional Use)
K050878 Cannabinoids (THC) Toxicology / TDM 05/17/2013
Alere Toxicology Services, Inc. Tox Screen Drugs of Abuse Test Cup  (Professional Use)
K050878 Phencyclidine (PCP) Toxicology / TDM 05/17/2013
Alere Toxicology Services, Inc. Tox Screen Drugs of Abuse Test Cup  (Professional Use)
K050878 Cocaine metabolites Toxicology / TDM 05/17/2013
Alere Toxicology Services, Inc. Tox Screen Drugs of Abuse Test Cup  (Professional Use)
K050878 Opiates Toxicology / TDM 05/17/2013
Alere Toxicology Services, Inc. Tox Screen Drugs of Abuse Test Cup  (Professional Use)
K050878 Methamphetamines Toxicology / TDM 05/17/2013
Alere Toxicology Services, Inc. Tox Screen Drugs of Abuse Test Cup  (Professional Use)
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/17/2013
mooremedical Urine Reagent Strips  
K061559 Urine qualitative dipstick ketone Urinalysis 05/17/2013
mooremedical Urine Reagent Strips  
K061559 Urine qualitative dipstick blood Urinalysis 05/17/2013
mooremedical Urine Reagent Strips  
K061559 Urine qualitative dipstick glucose Urinalysis 05/17/2013
mooremedical Urine Reagent Strips  
K061559 Urine qualitative dipstick leukocytes Urinalysis 05/17/2013
mooremedical Urine Reagent Strips  
K061559 Urine qualitative dipstick nitrite Urinalysis 05/17/2013
mooremedical Urine Reagent Strips  
K061559 Urine qualitative dipstick Ph Urinalysis 05/17/2013
mooremedical Urine Reagent Strips  
K061559 Urine qualitative dipstick protein Urinalysis 05/17/2013
mooremedical Urine Reagent Strips  
K061559 Urine qualitative dipstick urobilinogen Urinalysis 05/17/2013
mooremedical Urine Reagent Strips  
K061559 Urine qualitative dipstick specific gravity Urinalysis 05/17/2013
mooremedical Urine Reagent Strips  
K061559 Urine qualitative dipstick bilirubin Urinalysis 05/17/2013
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K130463 Propoxyphene Toxicology / TDM 05/15/2013
UCP Biosciences, Inc. UCP Home Drug Screening Test Cards  
K130463 Buprenorphine Toxicology / TDM 05/15/2013
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K130463 Propoxyphene Toxicology / TDM 05/15/2013
UCP Biosciences, Inc. UCP Home Drug Screening Test Cups  
K130463 Buprenorphine Toxicology / TDM 05/15/2013
BTNX, Inc. Rapid Response At-Home Pregnancy Test  
K122907 Urine hCG by visual color comparison tests Endocrinology 05/14/2013
Germaine Laboratories, Inc. AimTab BilirubinTablets  (Urine, qualitative bilirubin)
X130001 Urine dipstick or tablet analytes, nonautomated Urinalysis 05/13/2013
SDBiotek Corporation ForSure Buprenorphine Drug CupTest  
K122064 Opiates Toxicology / TDM 05/09/2013
CLIAwaived Inc. Rapid Dip Drug Test  
K082508 Buprenorphine Toxicology / TDM 05/02/2013
CLIAwaived Inc. Single Drug Dipstick Test  
K082508 Buprenorphine Toxicology / TDM 05/02/2013
Progressive Health Supply and Source Corp., Smartest GlucoWise Blood Glucose Monitoring System Model 6267-S  
K122525 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/02/2013
Progressive Health Supply and Source Corp., Smartest GlucoWise MULTI Blood Glucose Monitoring System Model 6267-M  
K122525 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/02/2013
Nipro Diagnostics True Metrix Pro Professional Monitoring Blood Glucose System  
K120989 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/24/2013
Nipro Diagnostics True Metrix Self Monitoring Blood Glucose System  
K120989 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/24/2013
BTNX Rapid Response hCG Pregnancy Serum/Urine Combo Test  
K112101 Urine hCG by visual color comparison tests Endocrinology 04/19/2013
Medline EvenCare G2 Blood Glucose Monitoring System  
K113098 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/19/2013
Fora Care DIAVUE Prudential Blood Glucose Monitoring System  
K122307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/16/2013
Guangzhou Wondfo Biotech Co., Ltd., Wondfo Multi-Drug Urine Test Cup  (Cup format)
K130665 Buprenorphine Toxicology / TDM 04/16/2013
Guangzhou Wondfo Biotech Co., Ltd., Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K130665 Buprenorphine Toxicology / TDM 04/16/2013
Healgen hCG One Step Pregnancy Test strip  
K123703 Urine hCG by visual color comparison tests Endocrinology 04/16/2013
Healgen hCG One Step Pregnancy Test Cassette  
K123703 Urine hCG by visual color comparison tests Endocrinology 04/16/2013
Henry Schein Urispec 5-Way Plus Reagent Test Strips  
K991927 Urine qualitative dipstick blood Urinalysis 04/16/2013
Henry Schein Urispec 5-Way Plus Reagent Test Strips  
K991927 Urine qualitative dipstick glucose Urinalysis 04/16/2013
Henry Schein Urispec 5-Way Plus Reagent Test Strips  
K991927 Urine qualitative dipstick leukocytes Urinalysis 04/16/2013
Henry Schein Urispec 5-Way Plus Reagent Test Strips  
K991927 Urine qualitative dipstick nitrite Urinalysis 04/16/2013
Henry Schein Urispec 5-Way Plus Reagent Test Strips  
K991927 Urine qualitative dipstick protein Urinalysis 04/16/2013
Henry Schein Urispec 5-Way Plus Reagent Test Strips  
K991927 Urine qualitative dipstick urobilinogen Urinalysis 04/16/2013
iHealth BG5 Wireless Smart Gluco-Monitoring System  
K123935 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/16/2013
iHealth BG5L Wireless Smart Gluco-Monitoring System  
K123935 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/16/2013
Nova Biomedical Nova Max Mini Glucose and B-Ketone Monitoring System  
K122688 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/16/2013
Nova Biomedical Nova Max Mini Glucose and B-Ketone Monitoring System  
K122688 Ketone, blood General Chemistry 04/16/2013
Chematics Inc. Alco-Screen Saliva Alcohol Test  
K121247 Alcohol, saliva Toxicology / TDM 03/25/2013
Polymed Therapeutics Fastep At-Home Pregnancy Test  
K122907 Urine hCG by visual color comparison tests Endocrinology 03/25/2013
Moore Medical, mooremedical Urine Analyzer U120  
K070929 Urine qualitative dipstick ketone Urinalysis 03/15/2013
Moore Medical, mooremedical Urine Analyzer U120  
K070929 Urine qualitative dipstick bilirubin Urinalysis 03/15/2013
Moore Medical, mooremedical Urine Analyzer U120  
K070929 Urine qualitative dipstick blood Urinalysis 03/15/2013
Moore Medical, mooremedical Urine Analyzer U120  
K070929 Urine qualitative dipstick glucose Urinalysis 03/15/2013
Moore Medical, mooremedical Urine Analyzer U120  
K070929 Urine qualitative dipstick leukocytes Urinalysis 03/15/2013
Moore Medical, mooremedical Urine Analyzer U120  
K070929 Urine qualitative dipstick nitrite Urinalysis 03/15/2013
Moore Medical, mooremedical Urine Analyzer U120  
K070929 Urine qualitative dipstick Ph Urinalysis 03/15/2013
Moore Medical, mooremedical Urine Analyzer U120  
K070929 Urine qualitative dipstick protein Urinalysis 03/15/2013
Moore Medical, mooremedical Urine Analyzer U120  
K070929 Urine qualitative dipstick urobilinogen Urinalysis 03/15/2013
Moore Medical, mooremedical Urine Analyzer U120  
K070929 Urine qualitative dipstick specific gravity Urinalysis 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K121166 Phencyclidine (PCP) Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K121166 Cocaine metabolites Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K121166 Opiates Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K121166 Methadone Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K121166 Methamphetamines Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K121166 Morphine Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K121166 Tricyclic antidepressants Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K121166 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Panel  
K122904 Amphetamines Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Panel  
K122904 Cannabinoids (THC) Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Panel  
K122904 Phencyclidine (PCP) Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Panel  
K122904 Cocaine metabolites Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Panel  
K122904 Methadone Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Panel  
K122904 Methamphetamines Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Panel  
K122904 Benzodiazepines Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Panel  
K122904 Barbiturates Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Panel  
K122904 Morphine Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Panel  
K122904 Tricyclic antidepressants Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Panel  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/15/2013
Nobel Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Panel  
K122904 Oxycodone Toxicology / TDM 03/15/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K122904 Amphetamines Toxicology / TDM 03/15/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K122904 Cannabinoids (THC) Toxicology / TDM 03/15/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K122904 Phencyclidine (PCP) Toxicology / TDM 03/15/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K122904 Cocaine metabolites Toxicology / TDM 03/15/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K122904 Methadone Toxicology / TDM 03/15/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K122904 Methamphetamines Toxicology / TDM 03/15/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K122904 Benzodiazepines Toxicology / TDM 03/15/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K122904 Barbiturates Toxicology / TDM 03/15/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K122904 Morphine Toxicology / TDM 03/15/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K122904 Tricyclic antidepressants Toxicology / TDM 03/15/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K122904 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/15/2013
Noble Medical Inc. INSTA-SCREEN Multi-Drug Urine Test Cup  
K122904 Oxycodone Toxicology / TDM 03/15/2013
Philosys Gmate VOICE Blood Glucose Monitoring System  
K113636 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/15/2013
Henry Schein OneStep Pro+ Mono  (Whole Blood)
K961024 Infectious mononucleosis antibodies (mono) General Immunology 03/11/2013
Henry Schein URISPEC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick ketone Urinalysis 03/11/2013
Henry Schein URISPEC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick bilirubin Urinalysis 03/11/2013
Henry Schein URISPEC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick blood Urinalysis 03/11/2013
Henry Schein URISPEC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick glucose Urinalysis 03/11/2013
Henry Schein URISPEC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick leukocytes Urinalysis 03/11/2013
Henry Schein URISPEC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick nitrite Urinalysis 03/11/2013
Henry Schein URISPEC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick Ph Urinalysis 03/11/2013
Henry Schein URISPEC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick protein Urinalysis 03/11/2013
Henry Schein URISPEC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick urobilinogen Urinalysis 03/11/2013
Henry Schein URISPEC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick specific gravity Urinalysis 03/11/2013
Vertex Diagnostics, UltraTRAK COMPLETE Blood Glucose Monitoring System  
K073492 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/04/2013
BTNX Rapid Response Thyroid Stimulating Hormone (TSH) Test Cassette (Whole Blood)  
K030912 Thyroid stimulating hormone (TSH) Endocrinology 03/01/2013
Fifty50 Medical Fifty50 Sport Blood Glucose Monitoring System 2.0  
K120351 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife AC-300 Blood Glucose Monitoring System  
K113307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife AC-300 Professional Blood Glucose Monitoring System  
K113307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife AC-301 Blood Glucose Monitoring System  
K113307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife AC-301 Professional Blood Glucose Monitoring System  
K113307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife AC-302 Blood Glucose Monitoring System  
K113307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife AC-302 Professional Blood Glucose Monitoring System  
K113307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife AC-303 Blood Glucose Monitoring System  
K113307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife AC-303 Professional Blood Glucose Monitoring System  
K113307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife AC-304 Blood Glucose Monitoring System  
K113307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife AC-304 Professional Blood Glucose Monitoring System  
K113307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife AC-305 Blood Glucose Monitoring System  
K113307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife AC-305 Professional Blood Glucose Monitoring System  
K113307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife CS-200 Blood Glucose Monitoring System  
K121433 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
GoodLife CS-200 Professional Blood Glucose Monitoring System  
K121433 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
Roche Diagnostics ACCU-CHEK Compact Plus Blood Glucose Monitoring System  
K113614 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Amphetamines Toxicology / TDM 02/27/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Cannabinoids (THC) Toxicology / TDM 02/27/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Phencyclidine (PCP) Toxicology / TDM 02/27/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Cocaine metabolites Toxicology / TDM 02/27/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Opiates Toxicology / TDM 02/27/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Methadone Toxicology / TDM 02/27/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Methamphetamines Toxicology / TDM 02/27/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Benzodiazepines Toxicology / TDM 02/27/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Barbiturates Toxicology / TDM 02/27/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Morphine Toxicology / TDM 02/27/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Tricyclic antidepressants Toxicology / TDM 02/27/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/27/2013
American Screening Corporation Discover Drug Test Cards  
K123863 Oxycodone Toxicology / TDM 02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups  
K123863 Amphetamines Toxicology / TDM 02/27/2013
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K123863 Cannabinoids (THC) Toxicology / TDM 02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups  
K123863 Phencyclidine (PCP) Toxicology / TDM 02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups  
K123863 Cocaine metabolites Toxicology / TDM 02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups  
K123863 Opiates Toxicology / TDM 02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups  
K123863 Methadone Toxicology / TDM 02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups  
K123863 Methamphetamines Toxicology / TDM 02/27/2013
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K123863 Benzodiazepines Toxicology / TDM 02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups  
K123863 Barbiturates Toxicology / TDM 02/27/2013
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K123863 Morphine Toxicology / TDM 02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups  
K123863 Tricyclic antidepressants Toxicology / TDM 02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups  
K123863 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups  
K123863 Oxycodone Toxicology / TDM 02/27/2013
Cliawaived Inc. Auto Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick specific gravity Urinalysis 02/22/2013
Cliawaived Inc. Auto Urinalysis Reagent Strips  
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Cliawaived Inc. Auto Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick bilirubin Urinalysis 02/22/2013
Cliawaived Inc. Auto Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick blood Urinalysis 02/22/2013
Cliawaived Inc. Auto Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick glucose Urinalysis 02/22/2013
Cliawaived Inc. Auto Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick leukocytes Urinalysis 02/22/2013
Cliawaived Inc. Auto Urinalysis Reagent Strips  
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Cliawaived Inc. Auto Urinalysis Reagent Strips  
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Cliawaived Inc. Auto Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick protein Urinalysis 02/22/2013
Cliawaived Inc. Auto Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick urobilinogen Urinalysis 02/22/2013
Wondfo Buprenorphine Urine Test  (Dip Card format)
K130055 Buprenorphine Toxicology / TDM 02/15/2013
Wondfo Buprenorphine Urine Test  (Cup format)
K130055 Buprenorphine Toxicology / TDM 02/15/2013
Ceragem Medisys LabonaCheck Gluppy Blood Glucose Monitoring System  
K102751 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/14/2013
Home Aide Diagnostics, Inc., Easy Plus II Blood Glucose Monitoring System  
K100560 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/14/2013
Henry Schein OneStep+Influenza A&B Test  
K103610 Influenza A/B Virology 02/13/2013
EGENS One Step HCG Urine Pregnancy Test Kit (Cassette)  
K123050 hCG, Urine Endocrinology 02/11/2013
EGENS One Step HCG Urine Pregnancy Test Kit (Midstream I)  
K123050 hCG, Urine Endocrinology 02/11/2013
EGENS One Step HCG Urine Pregnancy Test Kit (Midstream II)  
K123050 hCG, Urine Endocrinology 02/11/2013
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K123050 hCG, Urine Endocrinology 02/11/2013
Branan Medical Corporation ToxCup Drug Screen Cup  (Cassette Dip Card format)
K122633 Amphetamines Toxicology / TDM 02/08/2013
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K122633 Buprenorphine Toxicology / TDM 02/08/2013
CLIAwaived, Inc. Rapid Drug Test Cup  
K052115 Amphetamines Toxicology / TDM 02/08/2013
CLIAwaived, Inc. Rapid Drug Test Cup  
K052115 Cannabinoids (THC) Toxicology / TDM 02/08/2013
CLIAwaived, Inc. Rapid Drug Test Cup  
K052115 Phencyclidine (PCP) Toxicology / TDM 02/08/2013
CLIAwaived, Inc. Rapid Drug Test Cup  
K052115 Cocaine metabolites Toxicology / TDM 02/08/2013
CLIAwaived, Inc. Rapid Drug Test Cup  
K052115 Opiates Toxicology / TDM 02/08/2013
CLIAwaived, Inc. Rapid Drug Test Cup  
K052115 Methadone Toxicology / TDM 02/08/2013
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K052115 Methamphetamines Toxicology / TDM 02/08/2013
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K052115 Benzodiazepines Toxicology / TDM 02/08/2013
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K052115 Tricyclic antidepressants Toxicology / TDM 02/08/2013
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K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/08/2013
CLIAwaived, Inc. Rapid Drug Test Cup  
K052115 Oxycodone Toxicology / TDM 02/08/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  
K052115 Amphetamines Toxicology / TDM 02/08/2013
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K052115 Cannabinoids (THC) Toxicology / TDM 02/08/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  
K052115 Phencyclidine (PCP) Toxicology / TDM 02/08/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  
K052115 Cocaine metabolites Toxicology / TDM 02/08/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  
K052115 Opiates Toxicology / TDM 02/08/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  
K052115 Methadone Toxicology / TDM 02/08/2013
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K052115 Methamphetamines Toxicology / TDM 02/08/2013
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K052115 Benzodiazepines Toxicology / TDM 02/08/2013
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K052115 Barbiturates Toxicology / TDM 02/08/2013
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K052115 Tricyclic antidepressants Toxicology / TDM 02/08/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/08/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  
K052115 Oxycodone Toxicology / TDM 02/08/2013
LifeScan OneTouch Verio Sync Blood Glucose Monitoring System  
K120708 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/08/2013
Noble Medical Inc. NOBLE 1 Step Cup  
K052115 Amphetamines Toxicology / TDM 02/08/2013
Noble Medical Inc. NOBLE 1 Step Cup  
K052115 Cannabinoids (THC) Toxicology / TDM 02/08/2013
Noble Medical Inc. NOBLE 1 Step Cup  
K052115 Phencyclidine (PCP) Toxicology / TDM 02/08/2013
Noble Medical Inc. NOBLE 1 Step Cup  
K052115 Cocaine metabolites Toxicology / TDM 02/08/2013
Noble Medical Inc. NOBLE 1 Step Cup  
K052115 Opiates Toxicology / TDM 02/08/2013
Noble Medical Inc. NOBLE 1 Step Cup  
K052115 Methadone Toxicology / TDM 02/08/2013
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K052115 Methamphetamines Toxicology / TDM 02/08/2013
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K052115 Benzodiazepines Toxicology / TDM 02/08/2013
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K052115 Barbiturates Toxicology / TDM 02/08/2013
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K052115 Tricyclic antidepressants Toxicology / TDM 02/08/2013
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K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/08/2013
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K052115 Oxycodone Toxicology / TDM 02/08/2013
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K052115 Amphetamines Toxicology / TDM 02/08/2013
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K052115 Cocaine metabolites Toxicology / TDM 02/08/2013
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K052115 Opiates Toxicology / TDM 02/08/2013
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K052115 Benzodiazepines Toxicology / TDM 02/08/2013
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K052115 Tricyclic antidepressants Toxicology / TDM 02/08/2013
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K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/08/2013
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K052115 Oxycodone Toxicology / TDM 02/08/2013
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K052115 Amphetamines Toxicology / TDM 02/08/2013
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K052115 Cannabinoids (THC) Toxicology / TDM 02/08/2013
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K052115 Phencyclidine (PCP) Toxicology / TDM 02/08/2013
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K052115 Cocaine metabolites Toxicology / TDM 02/08/2013
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K052115 Opiates Toxicology / TDM 02/08/2013
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K052115 Methadone Toxicology / TDM 02/08/2013
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K052115 Methamphetamines Toxicology / TDM 02/08/2013
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K052115 Benzodiazepines Toxicology / TDM 02/08/2013
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K052115 Barbiturates Toxicology / TDM 02/08/2013
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K052115 Tricyclic antidepressants Toxicology / TDM 02/08/2013
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K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/08/2013
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K052115 Oxycodone Toxicology / TDM 02/08/2013
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K122904 Amphetamines Toxicology / TDM 02/05/2013
Micro Distributing II, Ltd STAT CUP One Step Drug TEST Cup  (Cup format)
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K122904 Benzodiazepines Toxicology / TDM 02/05/2013
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Micro Distributing II, Ltd STAT DIP One Step Multi Drug Test Panel  (Dip Card format)
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K122904 Cannabinoids (THC) Toxicology / TDM 02/05/2013
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K122904 Benzodiazepines Toxicology / TDM 02/05/2013
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Tianjin New Bay Bioresearch Co., Ltd. QuikResponse One Step Midstream Early Pregnancy Test  (for home use)
K112449 Urine hCG by visual color comparison tests Endocrinology 01/30/2013
US Diagnostics Inc. UScreen Drugs of Abuse Cup  
K122904 Amphetamines Toxicology / TDM 01/30/2013
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K122904 Cannabinoids (THC) Toxicology / TDM 01/30/2013
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K122904 Benzodiazepines Toxicology / TDM 01/30/2013
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K122904 Barbiturates Toxicology / TDM 01/30/2013
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K122904 Oxycodone Toxicology / TDM 01/30/2013
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K121166 Phencyclidine (PCP) Toxicology / TDM 01/30/2013
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K121166 Cocaine metabolites Toxicology / TDM 01/30/2013
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K121166 Opiates Toxicology / TDM 01/30/2013
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K121166 Methadone Toxicology / TDM 01/30/2013
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K121166 Methamphetamines Toxicology / TDM 01/30/2013
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K121166 Morphine Toxicology / TDM 01/30/2013
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K121166 Tricyclic antidepressants Toxicology / TDM 01/30/2013
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K121166 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/30/2013
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K121166 Phencyclidine (PCP) Toxicology / TDM 01/30/2013
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K121166 Cocaine metabolites Toxicology / TDM 01/30/2013
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K121166 Opiates Toxicology / TDM 01/30/2013
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K121166 Methadone Toxicology / TDM 01/30/2013
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K121166 Methamphetamines Toxicology / TDM 01/30/2013
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K121166 Morphine Toxicology / TDM 01/30/2013
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K121166 Tricyclic antidepressants Toxicology / TDM 01/30/2013
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K121166 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/30/2013
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K122904 Amphetamines Toxicology / TDM 01/30/2013
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K122904 Cannabinoids (THC) Toxicology / TDM 01/30/2013
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K122904 Benzodiazepines Toxicology / TDM 01/30/2013
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K122904 Barbiturates Toxicology / TDM 01/30/2013
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K122904 Oxycodone Toxicology / TDM 01/30/2013
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K123008 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/29/2013
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K061742 Urine qualitative dipstick ketone Urinalysis 01/29/2013
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K061742 Urine qualitative dipstick bilirubin Urinalysis 01/29/2013
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K061742 Urine qualitative dipstick blood Urinalysis 01/29/2013
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K061742 Urine qualitative dipstick glucose Urinalysis 01/29/2013
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K061742 Urine qualitative dipstick leukocytes Urinalysis 01/29/2013
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K061742 Urine qualitative dipstick Ph Urinalysis 01/29/2013
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K061742 Urine qualitative dipstick protein Urinalysis 01/29/2013
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K061742 Urine qualitative dipstick urobilinogen Urinalysis 01/29/2013
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K061742 Urine qualitative dipstick specific gravity Urinalysis 01/29/2013
CLIAwaived Inc. Automated Urinalysis Test System  
K070929 Urine qualitative dipstick ketone Urinalysis 01/23/2013
CLIAwaived Inc. Automated Urinalysis Test System  
K070929 Urine qualitative dipstick bilirubin Urinalysis 01/23/2013
CLIAwaived Inc. Automated Urinalysis Test System  
K070929 Urine qualitative dipstick blood Urinalysis 01/23/2013
CLIAwaived Inc. Automated Urinalysis Test System  
K070929 Urine qualitative dipstick glucose Urinalysis 01/23/2013
CLIAwaived Inc. Automated Urinalysis Test System  
K070929 Urine qualitative dipstick leukocytes Urinalysis 01/23/2013
CLIAwaived Inc. Automated Urinalysis Test System  
K070929 Urine qualitative dipstick nitrite Urinalysis 01/23/2013
CLIAwaived Inc. Automated Urinalysis Test System  
K070929 Urine qualitative dipstick Ph Urinalysis 01/23/2013
CLIAwaived Inc. Automated Urinalysis Test System  
K070929 Urine qualitative dipstick protein Urinalysis 01/23/2013
CLIAwaived Inc. Automated Urinalysis Test System  
K070929 Urine qualitative dipstick urobilinogen Urinalysis 01/23/2013
CLIAwaived Inc. Automated Urinalysis Test System  
K070929 Urine qualitative dipstick specific gravity Urinalysis 01/23/2013
BinaxNOW Strep A Card  (direct from throat swab)
K960712 Streptococcus, group A Bacteriology 01/16/2013
Coag-Sense Prothrombin Time (PT/INR) Monitoring System {Professional Use} 
K050243 Prothrombin time (PT) Hematology 01/16/2013
Coag-Sense Self-Test Prothrombin Time (PT/INR) Monitoring System {Prescription Home Use} 
K093243 Prothrombin time (PT) Hematology 01/16/2013
Germaine Laboratories, Inc. AimTab Ketone Tablets  
X120051 Ketone, urine General Chemistry 01/16/2013
FORA V10 No Code Blood Glucose Monitoring System, model TD-4244  
K121706 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/14/2013
LifeScan OneTouch Ultra Blood Glucose Meter {Shasta Technologies LLC GenStrip Test Strips} 
K103542 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/11/2013
LifeScan OneTouch Ultra2 Blood Glucose Meter {Shasta Technologies LLC GenStrip Test Strips} 
K103542 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/11/2013
LifeScan OneTouch UltraMini Blood Glucose Meter {Shasta Technologies LLC GenStrip Test Strips} 
K103542 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/11/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Amphetamines Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Cannabinoids (THC) Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Phencyclidine (PCP) Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Cocaine metabolites Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Opiates Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Methadone Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Methamphetamines Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Benzodiazepines Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Barbiturates Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Morphine Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Tricyclic antidepressants Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cards  
K123863 Oxycodone Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Amphetamines Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Cannabinoids (THC) Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Phencyclidine (PCP) Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Cocaine metabolites Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Opiates Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Methadone Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Methamphetamines Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Benzodiazepines Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Barbiturates Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Morphine Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Tricyclic antidepressants Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/10/2013
UCP Biosciences, Inc. UCP Compact Drug Test Cups  
K123863 Oxycodone Toxicology / TDM 01/10/2013
Avie Total Hb Test System {Professional Use} 
K121752 Hemoglobin Hematology 01/07/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Amphetamines Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Cannabinoids (THC) Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Phencyclidine (PCP) Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Cocaine metabolites Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Opiates Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Methadone Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Methamphetamines Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Benzodiazepines Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Barbiturates Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Morphine Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Tricyclic antidepressants Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cards  
K091588 Oxycodone Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Amphetamines Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Cannabinoids (THC) Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Phencyclidine (PCP) Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Cocaine metabolites Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Opiates Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Methadone Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Methamphetamines Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Benzodiazepines Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Barbiturates Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Morphine Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Tricyclic antidepressants Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/04/2013
American Screening Corporation, Inc., Multi-Drug Testing Cups  
K110515 Oxycodone Toxicology / TDM 01/04/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Amphetamines Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Cannabinoids (THC) Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Phencyclidine (PCP) Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Cocaine metabolites Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Opiates Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Methadone Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Methamphetamines Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Benzodiazepines Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Barbiturates Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Tricyclic antidepressants Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/03/2013
Clinical Reference Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Oxycodone Toxicology / TDM 01/03/2013
OSOM® iFOB Test OSOM® iFOBT Control Kit  
K121397 Fecal occult blood General Chemistry 01/03/2013
Nova Biomedical Nova One Blood Glucose Monitoring System  
K122435 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/20/2012
ACON Laboratories, On Call Vivid Pro Blood Glucose Monitoring System  
K123010 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/17/2012
Delbio Incorporation DA01 Blood Glucose Monitoring System  
K120866 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/12/2012
Pharmaceutical Marketing Systems, Inc., Thyrotest Whole Blood TSH Test  
K030912 Thyroid stimulating hormone (TSH) Endocrinology 12/11/2012
SPD Swiss Precision Diagnostics GmbH Clearblue Advanced Pregnancy Test with Weeks Estimator  
K112870 hCG, Urine Endocrinology 12/11/2012
iHealth, SmartGluco - Monitoring System (BG3)  
K120813 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/07/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K123080 Opiates Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K123080 Methadone Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K123080 Benzodiazepines Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K123080 Barbiturates Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K123080 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K123080 Oxycodone Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K123080 Opiates Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K123080 Methadone Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K123080 Benzodiazepines Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K123080 Barbiturates Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K123080 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/29/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K123080 Oxycodone Toxicology / TDM 11/29/2012
Alere iCup DX Drug Screen Cup  
K052115 Amphetamines Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Cannabinoids (THC) Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Phencyclidine (PCP) Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Cocaine metabolites Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Opiates Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Methadone Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Methamphetamines Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Benzodiazepines Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Barbiturates Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Tricyclic antidepressants Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 11/27/2012
Alere iCup DX Drug Screen Cup  
K052115 Oxycodone Toxicology / TDM 11/27/2012
On Call Vivid Pal Blood Glucose Monitoring System (ACON Laboratories)  
K122110 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/26/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K122904 Amphetamines Toxicology / TDM 11/16/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K122904 Cannabinoids (THC) Toxicology / TDM 11/16/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K122904 Benzodiazepines Toxicology / TDM 11/16/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K122904 Barbiturates Toxicology / TDM 11/16/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K122904 Oxycodone Toxicology / TDM 11/16/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K122904 Amphetamines Toxicology / TDM 11/16/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K122904 Cannabinoids (THC) Toxicology / TDM 11/16/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K122904 Benzodiazepines Toxicology / TDM 11/16/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K122904 Barbiturates Toxicology / TDM 11/16/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K122904 Oxycodone Toxicology / TDM 11/16/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Amphetamines Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Cannabinoids (THC) Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Phencyclidine (PCP) Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Cocaine metabolites Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Opiates Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Methadone Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Methamphetamines Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Benzodiazepines Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Barbiturates Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Tricyclic antidepressants Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 10/23/2012
Clinical Research Laboratory, Inc. Intelligent Transport Cup  (OTC)
K052115 Oxycodone Toxicology / TDM 10/23/2012
Jant Pharmacal Corp. Accutest Multi X Drug Cup Test  
K071489 Amphetamines Toxicology / TDM 10/23/2012
Jant Pharmacal Corp. Accutest Multi X Drug Cup Test  
K071489 Cannabinoids (THC) Toxicology / TDM 10/23/2012
Jant Pharmacal Corp. Accutest Multi X Drug Cup Test  
K071489 Phencyclidine (PCP) Toxicology / TDM 10/23/2012
Jant Pharmacal Corp. Accutest Multi X Drug Cup Test  
K071489 Cocaine metabolites Toxicology / TDM 10/23/2012
Jant Pharmacal Corp. Accutest Multi X Drug Cup Test  
K071489 Methadone Toxicology / TDM 10/23/2012
Jant Pharmacal Corp. Accutest Multi X Drug Cup Test  
K071489 Methamphetamines Toxicology / TDM 10/23/2012
Jant Pharmacal Corp. Accutest Multi X Drug Cup Test  
K071489 Benzodiazepines Toxicology / TDM 10/23/2012
Jant Pharmacal Corp. Accutest Multi X Drug Cup Test  
K071489 Barbiturates Toxicology / TDM 10/23/2012
Jant Pharmacal Corp. Accutest Multi X Drug Cup Test  
K071489 Morphine Toxicology / TDM 10/23/2012
Jant Pharmacal Corp. Accutest Multi X Drug Cup Test  
K071489 Tricyclic antidepressants Toxicology / TDM 10/23/2012
Jant Pharmacal Corp. Accutest Multi X Drug Cup Test  
K071489 Oxycodone Toxicology / TDM 10/23/2012
Roche Diagnostics ACCU-CHEK Inform II Blood Glucose Monitoring System  
K121679 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/15/2012
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489 Amphetamines Toxicology / TDM 10/11/2012
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489 Cannabinoids (THC) Toxicology / TDM 10/11/2012
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489 Phencyclidine (PCP) Toxicology / TDM 10/11/2012
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489 Cocaine metabolites Toxicology / TDM 10/11/2012
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489 Methadone Toxicology / TDM 10/11/2012
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489 Methamphetamines Toxicology / TDM 10/11/2012
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489 Benzodiazepines Toxicology / TDM 10/11/2012
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489 Barbiturates Toxicology / TDM 10/11/2012
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489 Morphine Toxicology / TDM 10/11/2012
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489 Tricyclic antidepressants Toxicology / TDM 10/11/2012
Revolution Diagnostics Corp. AccuSeal Pro Instant Test Cup  
K071489 Oxycodone Toxicology / TDM 10/11/2012
Arkray USA, Inc. GLUCOCARD Expression Blood Glucose Monitoring System  
K113098 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/09/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489 Amphetamines Toxicology / TDM 10/05/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489 Cannabinoids (THC) Toxicology / TDM 10/05/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489 Phencyclidine (PCP) Toxicology / TDM 10/05/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489 Cocaine metabolites Toxicology / TDM 10/05/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489 Methadone Toxicology / TDM 10/05/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489 Methamphetamines Toxicology / TDM 10/05/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489 Benzodiazepines Toxicology / TDM 10/05/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489 Barbiturates Toxicology / TDM 10/05/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489 Morphine Toxicology / TDM 10/05/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489 Tricyclic antidepressants Toxicology / TDM 10/05/2012
Medimpex United, Inc. MedimpexQ Test Multi X Drug Cup Test  
K071489 Oxycodone Toxicology / TDM 10/05/2012
Acon Laboratories, Inc. Insight U120 Urine Analyzer  
K070929 Urine qualitative dipstick ketone Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight U120 Urine Analyzer  
K070929 Urine qualitative dipstick bilirubin Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight U120 Urine Analyzer  
K070929 Urine qualitative dipstick blood Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight U120 Urine Analyzer  
K070929 Urine qualitative dipstick glucose Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight U120 Urine Analyzer  
K070929 Urine qualitative dipstick leukocytes Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight U120 Urine Analyzer  
K070929 Urine qualitative dipstick nitrite Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight U120 Urine Analyzer  
K070929 Urine qualitative dipstick Ph Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight U120 Urine Analyzer  
K070929 Urine qualitative dipstick protein Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight U120 Urine Analyzer  
K070929 Urine qualitative dipstick urobilinogen Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight U120 Urine Analyzer  
K070929 Urine qualitative dipstick specific gravity Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight U120 Urine Analyzer  
K070929 Urine qualitative dipstick ascorbic acid Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight Urinalysis Reagent Strips (Urine)  
K061559 Urine qualitative dipstick ketone Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight Urinalysis Reagent Strips (Urine)  
K061559 Urine qualitative dipstick bilirubin Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight Urinalysis Reagent Strips (Urine)  
K061559 Urine qualitative dipstick blood Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight Urinalysis Reagent Strips (Urine)  
K061559 Urine qualitative dipstick glucose Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight Urinalysis Reagent Strips (Urine)  
K061559 Urine qualitative dipstick leukocytes Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight Urinalysis Reagent Strips (Urine)  
K061559 Urine qualitative dipstick nitrite Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight Urinalysis Reagent Strips (Urine)  
K061559 Urine qualitative dipstick Ph Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight Urinalysis Reagent Strips (Urine)  
K061559 Urine qualitative dipstick protein Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight Urinalysis Reagent Strips (Urine)  
K061559 Urine qualitative dipstick urobilinogen Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight Urinalysis Reagent Strips (Urine)  
K061559 Urine qualitative dipstick specific gravity Urinalysis 09/26/2012
Acon Laboratories, Inc. Insight Urinalysis Reagent Strips (Urine)  
K061559 Urine qualitative dipstick ascorbic acid Urinalysis 09/26/2012
Moore Medical, Mooremedical hCG Serum/Urine Test-Cassette  
K993065 Urine hCG by visual color comparison tests Endocrinology 09/25/2012
Moore Medical, Mooremedical hCG Urine -Dipstick  
K993203 Urine hCG by visual color comparison tests Endocrinology 09/25/2012
Moore Medical, Mooremedical hCG Urine-Cassette  
K993317 Urine hCG by visual color comparison tests Endocrinology 09/25/2012
SCI International Inc. New Choice Urinary Tract Infection (UTI) Test Strips  
K103037 Urine qualitative dipstick leukocytes Urinalysis 09/25/2012
SCI International Inc. New Choice Urinary Tract Infection (UTI) Test Strips  
K103037 Urine qualitative dipstick nitrite Urinalysis 09/25/2012
Genesis Health Technologies, LLC Genesis Health Technologies TD-4123 Blood Glucose Monitoring System  
K121224 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/20/2012
Roche Diagnostics CoaguChek XS Plus System  
K071041 Prothrombin time (PT) Hematology 09/18/2012
Alere BinaxNOW Influenza A & B Card  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens)
K092223 Influenza A/B Virology 09/13/2012
Alere BinaxNOW Influenza A & B Card  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens)
K062109 Influenza A/B Virology 09/13/2012
Alere BinaxNOW Influenza A & B Card  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens)
K053126 Influenza A/B Virology 09/13/2012
Alere BinaxNOW Influenza A & B Card  (Nasal Wash/Aspirate Specimens)
K041049 Influenza A/B Virology 09/13/2012
Alere BinaxNOW RSV Card  
K032166 Respiratory syncytial virus Virology 09/13/2012
Alere BinaxNOW RSV Card  
K021687 Respiratory syncytial virus Virology 09/13/2012
Chematics Inc. Alco-Screen 02 Saliva Alcohol Test  
K121256 Alcohol, saliva Toxicology / TDM 09/13/2012
HMD Biomedical PRECICHEK Cloudia Blood Glucose Monitoring System  
K120064 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/10/2012
i-SENS USA, Inc., Auto-Chek Blood Glucose Monitoring System  
K121654 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/10/2012
Bionime GE 300 Talking Blood Glucose Monitoring system  
K120423 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/27/2012
Bionime Rightest Blood Glucose Monitoring System, Model GM650  
K120423 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/27/2012
CLIAwaived Inc. Instant Nicotine Detection Test  
K963733 Nicotine and/or metabolites Toxicology / TDM 08/27/2012
Experian Health, Phinex Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick ketone Urinalysis 08/27/2012
Experian Health, Phinex Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick bilirubin Urinalysis 08/27/2012
Experian Health, Phinex Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick blood Urinalysis 08/27/2012
Experian Health, Phinex Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick glucose Urinalysis 08/27/2012
Experian Health, Phinex Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick leukocytes Urinalysis 08/27/2012
Experian Health, Phinex Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick nitrite Urinalysis 08/27/2012
Experian Health, Phinex Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick Ph Urinalysis 08/27/2012
Experian Health, Phinex Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick protein Urinalysis 08/27/2012
Experian Health, Phinex Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick urobilinogen Urinalysis 08/27/2012
Experian Health, Phinex Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick specific gravity Urinalysis 08/27/2012
Germaine AimStrip Plus Blood Glucose Monitoring System  
K090057 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/27/2012
Medline Industries Medline Urinalysis Strips 10 Parameter Urine Reagent Strips  
K052719 Urine qualitative dipstick ketone Urinalysis 08/27/2012
Medline Industries Medline Urinalysis Strips 10 Parameter Urine Reagent Strips  
K052719 Urine qualitative dipstick bilirubin Urinalysis 08/27/2012
Medline Industries Medline Urinalysis Strips 10 Parameter Urine Reagent Strips  
K052719 Urine qualitative dipstick blood Urinalysis 08/27/2012
Medline Industries Medline Urinalysis Strips 10 Parameter Urine Reagent Strips  
K052719 Urine qualitative dipstick glucose Urinalysis 08/27/2012
Medline Industries Medline Urinalysis Strips 10 Parameter Urine Reagent Strips  
K052719 Urine qualitative dipstick leukocytes Urinalysis 08/27/2012
Medline Industries Medline Urinalysis Strips 10 Parameter Urine Reagent Strips  
K052719 Urine qualitative dipstick nitrite Urinalysis 08/27/2012
Medline Industries Medline Urinalysis Strips 10 Parameter Urine Reagent Strips  
K052719 Urine qualitative dipstick Ph Urinalysis 08/27/2012
Medline Industries Medline Urinalysis Strips 10 Parameter Urine Reagent Strips  
K052719 Urine qualitative dipstick protein Urinalysis 08/27/2012
Medline Industries Medline Urinalysis Strips 10 Parameter Urine Reagent Strips  
K052719 Urine qualitative dipstick urobilinogen Urinalysis 08/27/2012
Medline Industries Medline Urinalysis Strips 10 Parameter Urine Reagent Strips  
K052719 Urine qualitative dipstick specific gravity Urinalysis 08/27/2012
Simple Diagnostics, Clever Choice Voice+ M Blood Glucose Monitoring System  
K120921 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/27/2012
Simple Diagnostics, Clever Choice Voice+ S Blood Glucose Monitoring System  
K120921 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/27/2012
Simple Diagnostics, Clever Choice+ M Blood Glucose Monitoring System  
K120921 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/27/2012
Simple Diagnostics, Clever Choice+ S Blood Glucose Monitoring System  
K120921 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/27/2012
Tyson Bioresearch, Inc. TysonBio MD100 Blood Glucose Monitoring System  
K112916 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/27/2012
Tyson Bioresearch, Inc., TysonBio MD100 Pro Blood Glucose Monitoring System  
K112916 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/27/2012
Branan Medical Corporation Fastect II BUP Drug Screen Dipstick Test  
K082508 Buprenorphine Toxicology / TDM 08/24/2012
Branan Medical Corporation Fastect II Drug Screen Dipstick Test  
K082508 Buprenorphine Toxicology / TDM 08/24/2012
Branan Medical Corporation QuickTox Drug Screen Dipcard  
K082508 Buprenorphine Toxicology / TDM 08/24/2012
CLIAwaived Inc. Rapid Saliva Alcohol Test  
K093879 Ethanol (alcohol) Toxicology / TDM 08/16/2012
Stanbio Laboratory Uri-CON 10 Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick ketone Urinalysis 08/16/2012
Stanbio Laboratory Uri-CON 10 Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick bilirubin Urinalysis 08/16/2012
Stanbio Laboratory Uri-CON 10 Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick blood Urinalysis 08/16/2012
Stanbio Laboratory Uri-CON 10 Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick glucose Urinalysis 08/16/2012
Stanbio Laboratory Uri-CON 10 Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick leukocytes Urinalysis 08/16/2012
Stanbio Laboratory Uri-CON 10 Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick nitrite Urinalysis 08/16/2012
Stanbio Laboratory Uri-CON 10 Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick Ph Urinalysis 08/16/2012
Stanbio Laboratory Uri-CON 10 Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick protein Urinalysis 08/16/2012
Stanbio Laboratory Uri-CON 10 Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick urobilinogen Urinalysis 08/16/2012
Stanbio Laboratory Uri-CON 10 Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick specific gravity Urinalysis 08/16/2012
BioLand Technology Ltd. Bioland G-423 Blood Glucose Monitoring System  
K113077 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/09/2012
IND Diagnostic IND Home Amphetamine Test - Cassette Format  
K121231 Amphetamines Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Amphetamine Test - Strip Format  
K121231 Amphetamines Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Cocaine Test - Cassette Formate  
K121231 Cocaine metabolites Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Cocaine Test - Strip Format  
K121231 Cocaine metabolites Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Cassette Format  
K121231 Amphetamines Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Cassette Format  
K121231 Cannabinoids (THC) Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Cassette Format  
K121231 Cocaine metabolites Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Cassette Format  
K121231 Methamphetamines Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Cassette Format  
K121231 Morphine Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Strip Format  
K121231 Amphetamines Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Strip Format  
K121231 Cannabinoids (THC) Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Strip Format  
K121231 Cocaine metabolites Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Strip Format  
K121231 Methamphetamines Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Drug Test - Multi-Panel Strip Format  
K121231 Morphine Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Marijuana Test - Cassette Format  
K121231 Cannabinoids (THC) Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Marijuana Test - Strip Format  
K121231 Cannabinoids (THC) Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Methamphetamine Test - Cassette Format  
K121231 Methamphetamines Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Methamphetamine Test - Strip Format  
K121231 Methamphetamines Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Morphine Test - Cassette Format  
K121231 Morphine Toxicology / TDM 08/02/2012
IND Diagnostic IND Home Morphine Test - Strip Format  
K121231 Morphine Toxicology / TDM 08/02/2012
Wondfo Amphetamine Urine Test  (Dip Card format)
K121987 Amphetamines Toxicology / TDM 08/02/2012
Wondfo Amphetamine Urine Test  (Cup format)
K121987 Amphetamines Toxicology / TDM 08/02/2012
Wondfo Oxazepam Urine Test  (Dip Card format)
K121987 Benzodiazepines Toxicology / TDM 08/02/2012
Wondfo Oxazepam Urine Test  (Cup format)
K121987 Benzodiazepines Toxicology / TDM 08/02/2012
Wondfo Secobarbital Urine Test  (Dip Card format)
K121987 Barbiturates Toxicology / TDM 08/02/2012
Wondfo Secobarbital Urine Test  (Cup format)
K121987 Barbiturates Toxicology / TDM 08/02/2012
Wondfo Cannabinoids Urine Test  (Cup format)
K121557 Cannabinoids (THC) Toxicology / TDM 07/27/2012
Wondfo Cannabinoids Urine Test  (Dip Card format)
K121557 Cannabinoids (THC) Toxicology / TDM 07/27/2012
Bayer Contour Next Blood Glucose Monitoring System  
K121190 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/26/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K121166 Phencyclidine (PCP) Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K121166 Cocaine metabolites Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K121166 Methadone Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K121166 Methamphetamines Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K121166 Morphine Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K121166 Tricyclic antidepressants Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Cup  (Cup format)
K121166 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K121166 Phencyclidine (PCP) Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K121166 Cocaine metabolites Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K121166 Methadone Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K121166 Methamphetamines Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K121166 Morphine Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K121166 Tricyclic antidepressants Toxicology / TDM 07/24/2012
Wondfo Multi-Drug Urine Test Panel  (Dip Card format)
K121166 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/24/2012
Infopia USA, LLC. Healthpro Blood Glucose Monitoring System  
K113192 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/23/2012
bioLytical INSTI HIV-1 Antibody Test  (Fingerstick Whole Blood)
BP090032 HIV-1 antibody General Immunology 07/20/2012
OraSure Technologies, OraQuick In-Home HIV Test  (Oral Fluid)
BP120001 HIV antibodies General Immunology 07/20/2012
American Screening Corporation, HomeChek Reveal Blood Glucose Monitoring System  
K090057 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/17/2012
DAVAK Scientific, ReSure Blood Glucose Monitoring System  
K090057 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/17/2012
Polymed Therapeutics Fastep hCG Pregnancy Serum/Urine Combo Test  
K112101 Urine hCG by visual color comparison tests Endocrinology 07/17/2012
Meijer Distribution Inc., Meijer Deluxe Blood Glucose Monitoring System  
K073573 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Amphetamines Toxicology / TDM 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Cannabinoids (THC) Toxicology / TDM 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Phencyclidine (PCP) Toxicology / TDM 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Cocaine metabolites Toxicology / TDM 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Opiates Toxicology / TDM 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Methadone Toxicology / TDM 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Methamphetamines Toxicology / TDM 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Benzodiazepines Toxicology / TDM 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Barbiturates Toxicology / TDM 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Morphine Toxicology / TDM 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Tricyclic antidepressants Toxicology / TDM 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/13/2012
Ultimate Analysis Cup UA Cups  
K110515 Oxycodone Toxicology / TDM 07/13/2012
MHC Medical Products, LLC. EasyTouch Voice Premium Glucose Monitoring System  
K101543 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/12/2012
i-SENS, Inc. CareSens N Voice Blood Glucose Monitoring System  
K121133 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/11/2012
Apex BioTechnology Corp. AutoSure 3 Plus Voice Blood Glucose Monitoring System  
K120649 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/09/2012
Cardinal Health Leader Premium Blood Glucose Monitoring System  
K072413 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/09/2012
Germaine Laboratories, Inc. AimStrip Urine Reagent Strip  
K061559 Urine qualitative dipstick ketone Urinalysis 07/09/2012
Germaine Laboratories, Inc. AimStrip Urine Reagent Strip  
K061559 Urine qualitative dipstick Ph Urinalysis 07/09/2012
Germaine Laboratories, Inc. AimStrip Urine Reagent Strip  
K061559 Urine qualitative dipstick bilirubin Urinalysis 07/09/2012
Germaine Laboratories, Inc. AimStrip Urine Reagent Strip  
K061559 Urine qualitative dipstick blood Urinalysis 07/09/2012
Germaine Laboratories, Inc. AimStrip Urine Reagent Strip  
K061559 Urine qualitative dipstick glucose Urinalysis 07/09/2012
Germaine Laboratories, Inc. AimStrip Urine Reagent Strip  
K061559 Urine qualitative dipstick leukocytes Urinalysis 07/09/2012
Germaine Laboratories, Inc. AimStrip Urine Reagent Strip  
K061559 Urine qualitative dipstick nitrite Urinalysis 07/09/2012
Germaine Laboratories, Inc. AimStrip Urine Reagent Strip  
K061559 Urine qualitative dipstick protein Urinalysis 07/09/2012
Germaine Laboratories, Inc. AimStrip Urine Reagent Strip  
K061559 Urine qualitative dipstick urobilinogen Urinalysis 07/09/2012
Germaine Laboratories, Inc. AimStrip Urine Reagent Strip  
K061559 Urine qualitative dipstick specific gravity Urinalysis 07/09/2012
Topco Associates TopCare Blood Glucose Monitoring System  
K073573 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/09/2012
CLIAwaived Inc. Rapid Dip Drug Test  
K022355 Amphetamines Toxicology / TDM 07/03/2012
CLIAwaived Inc. Rapid Dip Drug Test  
K022355 Cannabinoids (THC) Toxicology / TDM 07/03/2012
CLIAwaived Inc. Rapid Dip Drug Test  
K022355 Phencyclidine (PCP) Toxicology / TDM 07/03/2012
CLIAwaived Inc. Rapid Dip Drug Test  
K022355 Cocaine metabolites Toxicology / TDM 07/03/2012
CLIAwaived Inc. Rapid Dip Drug Test  
K022355 Opiates Toxicology / TDM 07/03/2012
CLIAwaived Inc. Rapid Dip Drug Test  
K022355 Methadone Toxicology / TDM 07/03/2012
CLIAwaived Inc. Rapid Dip Drug Test  
K022355 Methamphetamines Toxicology / TDM 07/03/2012
CLIAwaived Inc. Rapid Dip Drug Test  
K022355 Benzodiazepines Toxicology / TDM 07/03/2012
CLIAwaived Inc. Rapid Dip Drug Test  
K022355 Barbiturates Toxicology / TDM 07/03/2012
CLIAwaived Inc. Rapid Dip Drug Test  
K022355 Oxycodone Toxicology / TDM 07/03/2012
CLIAwaived Inc. Rapid Dip Drug Test)  
K022355 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/03/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355 Amphetamines Toxicology / TDM 07/03/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355 Cannabinoids (THC) Toxicology / TDM 07/03/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355 Phencyclidine (PCP) Toxicology / TDM 07/03/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355 Cocaine metabolites Toxicology / TDM 07/03/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355 Opiates Toxicology / TDM 07/03/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355 Methadone Toxicology / TDM 07/03/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355 Methamphetamines Toxicology / TDM 07/03/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355 Benzodiazepines Toxicology / TDM 07/03/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355 Barbiturates Toxicology / TDM 07/03/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355 Tricyclic antidepressants Toxicology / TDM 07/03/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/03/2012
CLIAwaived Inc. Single Drug Dipstick Test  
K022355 Oxycodone Toxicology / TDM 07/03/2012
Target Corporation up&up Premium Blood Glucose Monitoring System  
K072413 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/20/2012
Topco Associates LLC TopCare Premium Blood Glucose Monitoring System  
K072413 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/20/2012
Stanbio Laboratory, Stanbio QuStick hCG Pregnancy Test  
K974368 Urine hCG by visual color comparison tests Endocrinology 06/14/2012
Jant Pharmacal Accutest Value + hCG 20 mIU/mL Urine Pregnancy Test Device  
K980531 Urine hCG by visual color comparison tests Endocrinology 06/13/2012
i-SENS, Inc. CareSens N Mini Blood Glucose Monitoring System  
K120759 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/08/2012
Mooremedical Strep A Rapid Test - Dipstick  
K010582 Streptococcus, group A Bacteriology 06/07/2012
Bayer A1C Now SelfCheck  
K090413 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 05/30/2012
Bayer A1CNow + Professional Use  
K090413 Glycosylated Hemoglobin (Hgb A1c) General Chemistry 05/30/2012
Health & Life Co. HL568 Self-Monitoring Blood Glucose System  
K110074 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/30/2012
BTNX Inc Rapid Response One Step HCG Urine/Serum Test  
K112071 Urine hCG by visual color comparison tests Endocrinology 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (COC/Cocaine)  (Dip Card format)
K112071 Cocaine metabolites Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (COC/Cocaine)  (Cup format)
K112071 Cocaine metabolites Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (MDMA/Methylenedioxymethamphetamine)  (Dip Card format)
K112071 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (MDMA/Methylenedioxymethamphetamine)  (Cup format)
K112071 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (MET/Methamphetamine)  (Dip Card format)
K112071 Methamphetamines Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (MET/Methamphetamine)  (Cup format)
K112071 Methamphetamines Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (MOP/Morphine)  (Cup format)
K112071 Morphine Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (MOP/Morphine)  (Dip Card format)
K112071 Morphine Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (MTD/Methadone)  (Cup format)
K112071 Methadone Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (MTD/Methadone)  (Dip Card format)
K112071 Methadone Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (PCP/Phencyclidine)  (Cup format)
K112071 Phencyclidine (PCP) Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test (PCP/Phencyclidine)  (Dip Card format)
K112071 Phencyclidine (PCP) Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test Cassette  
K112071 Cannabinoids (THC) Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test Cassette AMP/Amphetamine  
K112071 Amphetamines Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test Morphine (2000)  (Cup format)
K112071 Morphine Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test Morphine (2000)  (Dip Card format)
K112071 Morphine Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test Nortriptyline  (Cup format)
K112071 Tricyclic antidepressants Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test Nortriptyline  (Dip Card format)
K112071 Tricyclic antidepressants Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test Oxazepam Cassette  
K112071 Benzodiazepines Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test Oxazepam Strip  
K112071 Benzodiazepines Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test Secobarbital Cassette  
K112071 Barbiturates Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test Secobarbital Strip  
K112071 Barbiturates Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test Strip  
K112071 Cannabinoids (THC) Toxicology / TDM 05/29/2012
BTNX Inc Rapid Response X-Press Drug Test Strip AMP/Amphetamine  
K112071 Amphetamines Toxicology / TDM 05/29/2012
BTNX Rapid Response One Step HCG Urine Pregnancy Test  
K112071 Urine hCG by visual color comparison tests Endocrinology 05/29/2012
Alere Toxicology Services, iScreen Saliva Alcohol Test Strip  
K093879 Alcohol, saliva Toxicology / TDM 05/25/2012
American Screening Corporation, Reveal Saliva Alcohol Test Strip  
K093879 Alcohol, saliva Toxicology / TDM 05/25/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K121339 Amphetamines Toxicology / TDM 05/22/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K121339 Cannabinoids (THC) Toxicology / TDM 05/22/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K121339 Phencyclidine (PCP) Toxicology / TDM 05/22/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K121339 Cocaine metabolites Toxicology / TDM 05/22/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K121339 Methamphetamines Toxicology / TDM 05/22/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Cassette Tests  
K121339 Morphine Toxicology / TDM 05/22/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K121339 Amphetamines Toxicology / TDM 05/22/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K121339 Cannabinoids (THC) Toxicology / TDM 05/22/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K121339 Phencyclidine (PCP) Toxicology / TDM 05/22/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K121339 Cocaine metabolites Toxicology / TDM 05/22/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K121339 Methamphetamines Toxicology / TDM 05/22/2012
Chemtron Biotech, Inc. Chemtrue Single/Multi-Panel Drug Screen Dip Card Tests  
K121339 Morphine Toxicology / TDM 05/22/2012
EPS BioTechnology Corporation; EASYMAX MU Pro Self-monitoring Blood Glucose System  
K121207 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/22/2012
EPS BioTechnology Corporation; EASYMAX MU Self-monitoring Blood Glucose System  
K121207 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/22/2012
ADVOCATE Redi-Code BMB-EA001S Blood Glucose Monitoring System  
K120183 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/21/2012
i-SENS, Inc. CareSens N Pop Blood Glucose Monitoring System  
K120351 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/21/2012
Infopia Element Blood Glucose Monitoring System  
K113670 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/15/2012
LifeSign Status BTA  
K974845 Bladder tumor associated antigen General Immunology 05/15/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer  
K120124 Urine qualitative dipstick ketone Urinalysis 05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer  
K120124 Urine qualitative dipstick bilirubin Urinalysis 05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer  
K120124 Urine qualitative dipstick blood Urinalysis 05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer  
K120124 Urine qualitative dipstick glucose Urinalysis 05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer  
K120124 Urine qualitative dipstick leukocytes Urinalysis 05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer  
K120124 Urine qualitative dipstick nitrite Urinalysis 05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer  
K120124 Urine qualitative dipstick Ph Urinalysis 05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer  
K120124 Urine qualitative dipstick protein Urinalysis 05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer  
K120124 Urine qualitative dipstick urobilinogen Urinalysis 05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer  
K120124 Urine qualitative dipstick specific gravity Urinalysis 05/11/2012
Acon Laboratories, Inc. Foresight U120 Urine Analyzer  
K120124 Urine qualitative dipstick ascorbic acid Urinalysis 05/11/2012
Alere INRatio®2 PT/INR Home Monitoring System  (Prescription Home Use)
K110212 Prothrombin time (PT) Hematology 05/08/2012
Alere INRatio®2 PT/INR Monitoring System (Professional Use)  (Professional Use)
K110212 Prothrombin time (PT) Hematology 05/08/2012
BioSence Medical Devices, Solus V2 Audible Blood Glucose Monitoring System  
K093764 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/08/2012
Dale Medical Products, Inc. RightLevelpH  
X120015 Gastric pH General Chemistry 05/08/2012
Dale Medical Products, Inc. RightSpot pH  
X120015 Gastric pH General Chemistry 05/08/2012
McKesson 120 Urine Analyzer  
K120124 Urine qualitative dipstick ketone Urinalysis 05/08/2012
McKesson 120 Urine Analyzer  
K120124 Urine qualitative dipstick bilirubin Urinalysis 05/08/2012
McKesson 120 Urine Analyzer  
K120124 Urine qualitative dipstick blood Urinalysis 05/08/2012
McKesson 120 Urine Analyzer  
K120124 Urine qualitative dipstick glucose Urinalysis 05/08/2012
McKesson 120 Urine Analyzer  
K120124 Urine qualitative dipstick leukocytes Urinalysis 05/08/2012
McKesson 120 Urine Analyzer  
K120124 Urine qualitative dipstick nitrite Urinalysis 05/08/2012
McKesson 120 Urine Analyzer  
K120124 Urine qualitative dipstick Ph Urinalysis 05/08/2012
McKesson 120 Urine Analyzer  
K120124 Urine qualitative dipstick protein Urinalysis 05/08/2012
McKesson 120 Urine Analyzer  
K120124 Urine qualitative dipstick urobilinogen Urinalysis 05/08/2012
McKesson 120 Urine Analyzer  
K120124 Urine qualitative dipstick specific gravity Urinalysis 05/08/2012
McKesson 120 Urine Analyzer  
K120124 Urine qualitative dipstick ascorbic acid Urinalysis 05/08/2012
Apex Biotechnology Corp. GAL-1E Blood Glucose Monitoring System  
K113547 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/30/2012
Germaine Laboratories AimStrip Alcohol Saliva  
K093879 Alcohol, saliva Toxicology / TDM 04/30/2012
Major Biosystem Corporation, AP-3000 Blood Glucose Monitoring System  
K103230 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/30/2012
Major Biosystem Corporation, AP-3000multi Blood Glucose Monitoring System  
K103230 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/30/2012
McKesson Urine Reagent Strips  
K061559 Urine qualitative dipstick ketone Urinalysis 04/30/2012
McKesson Urine Reagent Strips  
K061559 Urine qualitative dipstick bilirubin Urinalysis 04/30/2012
McKesson Urine Reagent Strips  
K061559 Urine qualitative dipstick blood Urinalysis 04/30/2012
McKesson Urine Reagent Strips  
K061559 Urine qualitative dipstick glucose Urinalysis 04/30/2012
McKesson Urine Reagent Strips  
K061559 Urine qualitative dipstick leukocytes Urinalysis 04/30/2012
McKesson Urine Reagent Strips  
K061559 Urine qualitative dipstick nitrite Urinalysis 04/30/2012
McKesson Urine Reagent Strips  
K061559 Urine qualitative dipstick Ph Urinalysis 04/30/2012
McKesson Urine Reagent Strips  
K061559 Urine qualitative dipstick protein Urinalysis 04/30/2012
McKesson Urine Reagent Strips  
K061559 Urine qualitative dipstick urobilinogen Urinalysis 04/30/2012
McKesson Urine Reagent Strips  
K061559 Urine qualitative dipstick specific gravity Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer  
K070929 Urine qualitative dipstick ketone Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer  
K070929 Urine qualitative dipstick bilirubin Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer  
K070929 Urine qualitative dipstick blood Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer  
K070929 Urine qualitative dipstick glucose Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer  
K070929 Urine qualitative dipstick leukocytes Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer  
K070929 Urine qualitative dipstick nitrite Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer  
K070929 Urine qualitative dipstick Ph Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer  
K070929 Urine qualitative dipstick protein Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer  
K070929 Urine qualitative dipstick urobilinogen Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Analyzer  
K070929 Urine qualitative dipstick specific gravity Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips  
K061559 Urine qualitative dipstick ketone Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips  
K061559 Urine qualitative dipstick bilirubin Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips  
K061559 Urine qualitative dipstick blood Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips  
K061559 Urine qualitative dipstick glucose Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips  
K061559 Urine qualitative dipstick leukocytes Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips  
K061559 Urine qualitative dipstick nitrite Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips  
K061559 Urine qualitative dipstick Ph Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips  
K061559 Urine qualitative dipstick protein Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips  
K061559 Urine qualitative dipstick urobilinogen Urinalysis 04/30/2012
NDC Inc., Pro Advantage by NDC Urine Reagent Strips  
K061559 Urine qualitative dipstick specific gravity Urinalysis 04/30/2012
NewScen Coast Bio-Pharmaceutical Co. y.b.t. Pregnancy Test Cassette  
K112315 Urine hCG by visual color comparison tests Endocrinology 04/30/2012
NewScen Coast Bio-Pharmaceutical Co. y.b.t. Pregnancy Test Strip  
K112315 Urine hCG by visual color comparison tests Endocrinology 04/30/2012
IND Diagnostic, Inc. Urinary Tract Infection (UTI) Test Strips  
K103037 Urine qualitative dipstick leukocytes Urinalysis 04/25/2012
IND Diagnostic, Inc. Urinary Tract Infection (UTI) Test Strips  
K103037 Urine qualitative dipstick nitrite Urinalysis 04/25/2012
Rapid Pathogen Screening AdenoPlus test  (tear fluid)
K110722 Adenovirus Virology 04/24/2012
Sofia Analyzer and Influenza A+B FIA {For use with nasal swabs and nasopharyngeal swabs} 
K112177 Influenza A/B Virology 04/20/2012
Medline iFOB One-Step Immunological Fecal Occult Blood Test  
K100031 Fecal occult blood General Chemistry 04/19/2012
Acon Laboratories, On-Call Vivid Blood Glucose Monitoring System  
K112653 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/18/2012
Healgen Scientific LLC Healgen Reagent Strip for Urinalysis  (Manual - Qualitative)
K111999 Urine qualitative dipstick ketone Urinalysis 04/18/2012
Healgen Scientific LLC Healgen Reagent Strip for Urinalysis  (Manual - Qualitative)
K111999 Urine qualitative dipstick bilirubin Urinalysis 04/18/2012
Healgen Scientific LLC Healgen Reagent Strip for Urinalysis  (Manual - Qualitative)
K111999 Urine qualitative dipstick blood Urinalysis 04/18/2012
Healgen Scientific LLC Healgen Reagent Strip for Urinalysis  (Manual - Qualitative)
K111999 Urine qualitative dipstick glucose Urinalysis 04/18/2012
Healgen Scientific LLC Healgen Reagent Strip for Urinalysis  (Manual - Qualitative)
K111999 Urine qualitative dipstick leukocytes Urinalysis 04/18/2012
Healgen Scientific LLC Healgen Reagent Strip for Urinalysis  (Manual - Qualitative)
K111999 Urine qualitative dipstick nitrite Urinalysis 04/18/2012
Healgen Scientific LLC Healgen Reagent Strip for Urinalysis  (Manual - Qualitative)
K111999 Urine qualitative dipstick Ph Urinalysis 04/18/2012
Healgen Scientific LLC Healgen Reagent Strip for Urinalysis  (Manual - Qualitative)
K111999 Urine qualitative dipstick protein Urinalysis 04/18/2012
Healgen Scientific LLC Healgen Reagent Strip for Urinalysis  (Manual - Qualitative)
K111999 Urine qualitative dipstick urobilinogen Urinalysis 04/18/2012
Healgen Scientific LLC Healgen Reagent Strip for Urinalysis  (Manual - Qualitative)
K111999 Urine qualitative dipstick specific gravity Urinalysis 04/18/2012
Healgen Scientific LLC Healgen Reagent Strip for Urinalysis  (Manual - Qualitative)
K111999 Urine qualitative dipstick ascorbic acid Urinalysis 04/18/2012
Fora Care Inc, U-Right TD-4280 Blood Glucose Monitoring System  
K113768 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/17/2012
Apex Biotechnology Corporation MEG-2B Blood Glucose Monitoring System  
K120448 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/11/2012
Apex Biotechnology Corporation MEG-2B Pro Blood Glucose Monitoring System  
K120448 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/11/2012
McKesson Medical-Surgical McKesson hCG Combo Test-Cassette  
K993065 Urine hCG by visual color comparison tests Endocrinology 04/10/2012
McKesson Medical-Surgical, McKesson hCG Urine Test - Cassette  
K993317 Urine hCG by visual color comparison tests Endocrinology 04/10/2012
McKesson Medical-Surgical, McKesson hCG Urine Test - Dipstick  
K993203 Urine hCG by visual color comparison tests Endocrinology 04/10/2012
Medline Industries Medline hCG Urine Pregnancy Test Device  
K050741 Urine hCG by visual color comparison tests Endocrinology 04/10/2012
Medline Industries Medline hCG Urine Pregnancy Test Strip  
K951705 Urine hCG by visual color comparison tests Endocrinology 04/10/2012
Bionime USA Corporation Rightest Blood Glucose Monitoring System, Model GM700  
K110737 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/05/2012
Diaspect Hemoglobin Measuring System  
BK110036 Hemoglobin Hematology 04/05/2012
Bayer Contour Next Link Wireless Blood Glucose Monitoring System  
K110894 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/03/2012
GEMCO Medical, EM50 Self Monitoring Blood Glucose System  
K113243 Glucose monitoring devices (FDA cleared/home use) General Chemistry 04/03/2012
McKesson H. pylori Test {Whole Blood} 
K024350 Helicobacter pylori antibodies General Immunology 04/03/2012
Bayer Contour Link Wireless Blood Glucose Monitoring System  
K110587 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/28/2012
McKesson Strep A Test - Twist  
K023766 Streptococcus, group A Bacteriology 03/23/2012
Mckesson Strep A Test - Dipstick  
K010582 Streptococcus, group A Bacteriology 03/23/2012
Wondfo Oxycodone Urine Test  (Dip Card format)
K113624 Oxycodone Toxicology / TDM 03/14/2012
Wondfo Oxycodone Urine Test  (Cup format)
K113624 Oxycodone Toxicology / TDM 03/14/2012
Nova Biomedical Nova Max One Glucose Monitoring System  
K112638 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/13/2012
Contour NEXT EZ Blood Glucose Monitoring System  
K111268 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/12/2012
Quest Products, Inc. DrugHAWK Home Drug Test  
K082898 Amphetamines Toxicology / TDM 03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test  
K082898 Cannabinoids (THC) Toxicology / TDM 03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test  
K082898 Phencyclidine (PCP) Toxicology / TDM 03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test  
K082898 Cocaine metabolites Toxicology / TDM 03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test  
K082898 Opiates Toxicology / TDM 03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test  
K082898 Methadone Toxicology / TDM 03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test  
K082898 Methamphetamines Toxicology / TDM 03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test  
K082898 Benzodiazepines Toxicology / TDM 03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test  
K082898 Barbiturates Toxicology / TDM 03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test  
K082898 Tricyclic antidepressants Toxicology / TDM 03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test  
K082898 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/06/2012
Quest Products, Inc. DrugHAWK Home Drug Test  
K082898 Oxycodone Toxicology / TDM 03/06/2012
Sekisui Diagnostics, LLC OSOM Strep A Test  (direct from throat swab)
K961423 Streptococcus, group A Bacteriology 03/01/2012
Tianjin Empecs Medisign MM1000 Blood Glucose Monitoring System  
K111456 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2012
Tianjin Empecs Medisign MM1000 Multi-Blood Glucose Monitoring System  
K111456 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2012
Tianjin Empecs Medisign MM1100 Blood Glucose Monitoring System  
K111456 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2012
Tianjin Empecs Medisign MM1100 Multi-Blood Glucose Monitoring System  
K111456 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2012
Tianjin Empecs Medisign MM1200 Blood Glucose Monitoring System  
K111456 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2012
Tianjin Empecs Medisign MM1200 Multi-Blood Glucose Monitoring System  
K111456 Glucose monitoring devices (FDA cleared/home use) General Chemistry 03/01/2012
FreeStyle InsuLinx Blood Glucose Monitoring System  
K111874 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/22/2012
Tianjin New Bay Bioresearch Co., Ltd. ForeSure IFOB Dual-Sample Fecal Occult Blood Screen Card Test  
K073431 Fecal occult blood General Chemistry 02/22/2012
Sekisui Diagnostics, LLC, OSOM hCG Combo Test  
K043385 Urine hCG by visual color comparison tests Endocrinology 02/16/2012
Sekisui Diagnostics, LLC, OSOM ImmunoDip Urinary Albumin Test  
K043385 Albumin, urinary General Chemistry 02/16/2012
Sekisui Diagnostics, LLC, OSOM TRICHOMONAS RAPID TEST  
K043385 Trichomonas Parasitology 02/16/2012
Sekisui Diagnostics, LLC, OSOM ULTRA STREP A  
K043385 Streptococcus, group A Bacteriology 02/16/2012
Sekisui Diagnostics, LLC, SIGNIFY HCG URINE TEST  
K043385 Urine hCG by visual color comparison tests Endocrinology 02/16/2012
Sekisui Diagnostics, LLC, SIGNIFY MONO TEST  (For whole blood)
K043385 Infectious mononucleosis antibodies (mono) General Immunology 02/16/2012
AgaMatrix, Inc. Nugget Blood Glucose Monitoring System  
K103544 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/13/2012
ARKRAY ReliOn Prime Blood Glucose Monitoring System  
K091102 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/13/2012
Major Biosystem Corp. AP-1010 Blood Glucose Monitoring System  
K103044 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/13/2012
Major Biosystem Corp. AP-1010multi Blood Glucose Monitoring System  
K103044 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/13/2012
Major Biosystem Corp. AP-1020 Blood Glucose Monitoring System  
K103044 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/13/2012
Major Biosystem Corp. AP-1020multi Blood Glucose Monitoring System  
K103044 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/13/2012
Delta Products DiaCheck Smart Blood Glucose Monitoring System  
K113343 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/09/2012
Delta Products DiaCheck Superior Blood Glucose Monitoring System  
K113343 Glucose monitoring devices (FDA cleared/home use) General Chemistry 02/09/2012
PSS Consult H. pylori Cassette {Whole Blood, fingerstick only} 
K024350 Helicobacter pylori antibodies General Immunology 02/03/2012
Sekisui Diagnostics, LLC OSOM Trichomonas Rapid Test  
K033864 Trichomonas Parasitology 02/03/2012
Sekisui Diagnostics, LLC, OSOM Ultra Srep A Test  
K992658 Streptococcus, group A Bacteriology 02/03/2012
Apex Biotechnology Corp. GAL-1A Blood Glucose Monitoring System  
K113208 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/31/2012
Cambridge Sensors USA microdot Home Blood Glucose Monitoring System  
K102383 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/31/2012
Alere Influenza A & B Test {For use with Nasal Swabs only.} 
K092349 Influenza A/B Virology 01/27/2012
Alere iCassette Drug Screen  
K050050 Amphetamines Toxicology / TDM 01/26/2012
Alere iCassette Drug Screen  
K050050 Cannabinoids (THC) Toxicology / TDM 01/26/2012
Alere iCassette Drug Screen  
K050050 Phencyclidine (PCP) Toxicology / TDM 01/26/2012
Alere iCassette Drug Screen  
K050050 Cocaine metabolites Toxicology / TDM 01/26/2012
Alere iCassette Drug Screen  
K050050 Opiates Toxicology / TDM 01/26/2012
Alere iCassette Drug Screen  
K050050 Methamphetamines Toxicology / TDM 01/26/2012
Diabetic Supply of Suncoast, Inc., Advocate Redi-Code+ Blood Glucose Monitoring System  
K102316 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/26/2012
Sekisui Diagnostics, LLC OSOM ImmunoDip Urinary Albumin Test  
K011843 Albumin, urinary General Chemistry 01/26/2012
Syntron Bioresearch, Inc. URIGE-1 pH Urinalysis Strips  
K051727 Urine qualitative dipstick Ph Urinalysis 01/26/2012
Alere Triage MeterPro  (Whole Blood)
K021317 B-type natriuretic peptide (BNP) General Chemistry 01/23/2012
Simple Diagnostics AG-608N Multi Blood Glucose Montoring System  
K110017 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/23/2012
Simple Diagnostics AG-608N Single Blood Glucose Monitoring System  
K110017 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/23/2012
TearLab Corporation TearLab Osmolarity System  
K083184 Osmolality, tears General Chemistry 01/23/2012
Apex Biotechnology Corporation AutoSure Voice II Plus Blood Glucose Monitoring System  
K113098 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/19/2012
Major Biosystem Corp. AP-1000multi Blood Glucose Monitoring System  
K100437 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/13/2012
Alere San Diego Inc, Alere hCG Cassette (25 mIU/mL)  
K993317 hCG, Urine Endocrinology 01/11/2012
Alere San Diego Inc, Alere hCG Combo Cassette (20/10 mIU/mL)  
K062361 hCG, Urine Endocrinology 01/11/2012
Alere San Diego Inc, Alere hCG Combo Cassette (25 mIU/mL)  
K993065 hCG, Urine Endocrinology 01/11/2012
Alere San Diego Inc, Alere hCG Dipstick (25 mIU/mL)  
K993203 hCG, Urine Endocrinology 01/11/2012
Alere San Diego Inc. Alere hCG Cassette (20 mIU/mL)  
K062361 hCG, Urine Endocrinology 01/11/2012
Fora Care Inc. TD-4257 Blood Glucose Monitoring System  
K112963 Glucose General Chemistry 01/11/2012
Fora Care Inc. TD-4257 Multi Blood Glucose Monitoring System  
K112963 Glucose General Chemistry 01/11/2012
Alfa Scientific Designs Inc. Oral-View Saliva Alcohol Test Strip  
K093879 Ethanol (alcohol) Toxicology / TDM 01/06/2012
Jant Pharmacal Corporation Accustrip Saliva Alcohol Test Strip  
K093879 Ethanol (alcohol) Toxicology / TDM 01/06/2012
Roche ACCU-CHEK Nano SmartView Blood Glucose Monitoring System  
K113137 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/06/2012
BD Veritor System for Rapid Detection of Flu A + B {For use with nasal swabs and nasopharyngeal swabs} (Includes a reader)
K112277 Influenza A/B Virology 01/04/2012
FORA Care, FORA D40d Blood Glucose plus Blood Pressure Monitoring System  
K101926 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/04/2012
FORA Care, FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System  
K101926 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/04/2012
Gemco Medical EME Pro Self-Monitoring Blood Glucose System  
K112901 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/04/2012
Gemco Medical EME Self-Monitoring Blood Glucose System  
K112901 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/04/2012
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System  
K090405 Triglyceride General Chemistry 01/04/2012
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System  
K090405 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/04/2012
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System  
K090405 HDL cholesterol General Chemistry 01/04/2012
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System  
K090405 Cholesterol General Chemistry 01/04/2012
VITROLIFE One Step Pregnancy Test Device (urine)  
K993317 Urine hCG by visual color comparison tests Endocrinology 01/04/2012
VITROLIFE One Step Pregnancy Test Device (urine/serum)  
K993065 Urine hCG by visual color comparison tests Endocrinology 01/04/2012
VITROLIFE ONE STEP PREGNANCY TEST STRIP (URINE)  
K993203 Urine hCG by visual color comparison tests Endocrinology 01/04/2012
Fora Care Inc. FORA Premium V10 Blood Glucose Monitoring System  
K112275 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/21/2011
Clearview Exact II Influenza A & B Test {For use with Nasal Swabs only.} 
K092349 Influenza A/B Virology 12/16/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen  
K041685 Amphetamines Toxicology / TDM 12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen  
K041685 Cannabinoids (THC) Toxicology / TDM 12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen  
K041685 Phencyclidine (PCP) Toxicology / TDM 12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen  
K041685 Cocaine metabolites Toxicology / TDM 12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen  
K041685 Propoxyphene Toxicology / TDM 12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen  
K041685 Benzodiazepines Toxicology / TDM 12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen  
K041685 Barbiturates Toxicology / TDM 12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen  
K041685 Morphine Toxicology / TDM 12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen  
K041685 Tricyclic antidepressants Toxicology / TDM 12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen  
K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/14/2011
Alere Toxicology Services Alere iCassette Dx Drug Screen  
K041685 Oxycodone Toxicology / TDM 12/14/2011
EPS Bio Technology Corp. Easyplus mini Master Driver Self-Monitoring Blood Glucose Test System  
K092887 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/14/2011
Jant Pharmacal Accustrip Value + Pregnancy Urine Test  (Dip-Strip)
K984079 Urine hCG by visual color comparison tests Endocrinology 12/13/2011
Stanbio Laboratory, Stanbio alpha One-Step Pregnancy Urine Test  (Dip-Strip)
K984079 Urine hCG by visual color comparison tests Endocrinology 12/13/2011
BD Veritor System for Rapid Detection of Flu A + B {For use with nasal and nasopharyngeal swabs} (Includes a reader)
K112277 Influenza A/B Virology 12/09/2011
sanofi-aventis U.S. LLC iBGStar Blood Glucose Monitoring System  
K103544 Glucose monitoring devices (FDA cleared/home use) General Chemistry 12/07/2011
LifeSign, LLC Status H. pylori {OSOM H. pylori} ((for whole blood)
K980798 Helicobacter pylori antibodies General Immunology 12/06/2011
LifeSign, LLC Status Strep A  
K983386 Streptococcus, group A Bacteriology 12/06/2011
Atlas Medical, ATLAS Home Pregnancy Test (Midstream Format)  
K102760 hCG, Urine Endocrinology 11/28/2011
OraQuick HCV Rapid Antibody Test and OraQuick HCV Visual Reference Panel  
P080027 Hepatitis C virus antibody General Immunology 11/28/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test  
K071489 Amphetamines Toxicology / TDM 11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test  
K071489 Cannabinoids (THC) Toxicology / TDM 11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test  
K071489 Phencyclidine (PCP) Toxicology / TDM 11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test  
K071489 Cocaine metabolites Toxicology / TDM 11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test  
K071489 Methadone Toxicology / TDM 11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test  
K071489 Methamphetamines Toxicology / TDM 11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test  
K071489 Benzodiazepines Toxicology / TDM 11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test  
K071489 Barbiturates Toxicology / TDM 11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test  
K071489 Morphine Toxicology / TDM 11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test  
K071489 Tricyclic antidepressants Toxicology / TDM 11/21/2011
APC Work Force Solutions Secure Check Multi Drug Cup Test  
K071489 Oxycodone Toxicology / TDM 11/21/2011
Element plus Blood Glucose Monitoring System  
K103021 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/08/2011
ARKRAY USA, Inc. DiaScreen Reagent Strips for Urinalysis (Glucose/Ketones)  (Over-The-Counter)
K033851 Urine qualitative dipstick ketone Urinalysis 11/07/2011
ARKRAY USA, Inc. DiaScreen Reagent Strips for Urinalysis (Glucose/Ketones)  (Over-The-Counter)
K033851 Urine qualitative dipstick glucose Urinalysis 11/07/2011
Fora Care Inc. TD-4277 Blood Glucose Monitoring System  
K100322 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/01/2011
Meijer Distribution Inc, Meijer Premium Blood Glucose Monitoring System  
K072413 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/01/2011
Meijer Distribution Inc., Meijer Blood Glucose Monitoring System  
K073573 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/01/2011
The Kroger Co., Kroger Premium Blood Glucose Monitoring System  
K072413 Glucose monitoring devices (FDA cleared/home use) General Chemistry 11/01/2011
Wondfo Cocaine Urine Test  (Dip Card format)
K112071 Cocaine metabolites Toxicology / TDM 10/31/2011
Wondfo Cocaine Urine Test  (Cup format)
K112071 Cocaine metabolites Toxicology / TDM 10/31/2011
Wondfo Methamphetamine Urine Test  (Dip Card format)
K112071 Methamphetamines Toxicology / TDM 10/31/2011
Wondfo Methamphetamine Urine Test  (Cup format)
K112071 Methamphetamines Toxicology / TDM 10/31/2011
Status iFOBT  
K100817 Fecal occult blood General Chemistry 10/19/2011
Acon Laboratories, On-Call Chosen Blood Glucose Monitoring System  
K111371 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/17/2011
AK Medical, Glucose Shepherd Blood Glucose Monitoring System  
K102316 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/17/2011
AK Medical, Glucose Shepherd Pro Blood Glucose Monitoring System  
K102316 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/17/2011
Arkray USA, Glucocard Expression Blood Glucose Monitoring System  
K102037 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/11/2011
Fora Care Inc PNC100 Digital Pregnancy Test  (for home use)
K103487 Urine hCG by visual color comparison tests Endocrinology 10/06/2011
Fora Care Inc TD-5301 Pregnancy Test  (for home use)
K103487 Urine hCG by visual color comparison tests Endocrinology 10/06/2011
Alere HemoPoint H2 Hemoglobin Measurement System  
K081719 Hemoglobin Hematology 10/05/2011
ACCU-CHEK Aviva Plus Blood Glucose Monitoring System  
K101299 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/04/2011
Drogueria FMC Distributors, COOL Blood Glucose Monitoring System  
K103396 Glucose monitoring devices (FDA cleared/home use) General Chemistry 10/04/2011
Teco Diagnostics Saliva Alcohol Test  
K111206 Ethanol (alcohol) Toxicology / TDM 10/04/2011
Delta Products Corporation DiaCheck Premium Blood Glucose Monitoring System  
K100806 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/28/2011
US Diagnostics, Inc. EasyGluco Plus Blood Glucose Monitoring System  
K110435 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/28/2011
Wondfo Methylenedioxymethamphetamine Urine Test  (Dip Card format)
K112236 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/28/2011
Wondfo Methylenedioxymethamphetamine Urine Test  (Cup format)
K112236 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/28/2011
Wondfo Morphine Urine Test  (Cup format)
K112236 Morphine Toxicology / TDM 09/28/2011
Wondfo Morphine Urine Test  (Dip Card format)
K112236 Morphine Toxicology / TDM 09/28/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips  
K061559 Urine qualitative dipstick ketone Urinalysis 09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips  
K061559 Urine qualitative dipstick bilirubin Urinalysis 09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips  
K061559 Urine qualitative dipstick blood Urinalysis 09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips  
K061559 Urine qualitative dipstick glucose Urinalysis 09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips  
K061559 Urine qualitative dipstick leukocytes Urinalysis 09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips  
K061559 Urine qualitative dipstick nitrite Urinalysis 09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips  
K061559 Urine qualitative dipstick Ph Urinalysis 09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips  
K061559 Urine qualitative dipstick protein Urinalysis 09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips  
K061559 Urine qualitative dipstick urobilinogen Urinalysis 09/26/2011
Immunostics Inc., Detector Uristrip+ Urine Reagent Strips  
K061559 Urine qualitative dipstick specific gravity Urinalysis 09/26/2011
LifeScan OneTouch Verio IQ Blood Glucose Monitoring System  
K110637 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/26/2011
Apex Biotechnology Corp. GAL-1C Blood Glucose Monitoring System  
K102816 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/20/2011
Clarity iCare Diagnostic LLC, CLARITY Advanced Glucose Monitoring System  
K063026 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/20/2011
CoaguSense Prothrombin Time (PT)/INR Monitoring System {Professional Use} 
K050243 Prothrombin time (PT) Hematology 09/20/2011
GEMCO Medical EM44 Pro Self Monitoring Blood Glucose System  
K112272 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/20/2011
GEMCO Medical EM44 Self Monitoring Blood Glucose System  
K112272 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/20/2011
Gemco Medical EMV3 Pro Self-Monitoring Blood Glucose System  
K111728 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/20/2011
Gemco Medical EMV3 Self-Monitoring Blood Gluose System  
K111728 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/20/2011
Merete Medical GmbH pH-EcoCare Comfort Test  
X110087 pH, urine General Chemistry 09/20/2011
Orient Gene Biotech - One Step Rapid FOB  
K110309 Fecal occult blood General Chemistry 09/20/2011
Mediwatch Urinewatch UTI Urinary Tract Infection Test Strips  
K063295 Nitrite, urine General Chemistry 09/15/2011
Mediwatch Urinewatch UTI Urinary Tract Infection Test Strips  
K063295 Leukocyte esterase, urinary Urinalysis 09/15/2011
ACON Laboratories Inc. Mission Saliva Alcohol Test Strip  
K093879 Ethanol (alcohol) Toxicology / TDM 09/13/2011
Amedica Biotech Instant Test Cup  
K082898 Amphetamines Toxicology / TDM 09/13/2011
Amedica Biotech Instant Test Cup  
K082898 Cannabinoids (THC) Toxicology / TDM 09/13/2011
Amedica Biotech Instant Test Cup  
K082898 Phencyclidine (PCP) Toxicology / TDM 09/13/2011
Amedica Biotech Instant Test Cup  
K082898 Cocaine metabolites Toxicology / TDM 09/13/2011
Amedica Biotech Instant Test Cup  
K082898 Opiates Toxicology / TDM 09/13/2011
Amedica Biotech Instant Test Cup  
K082898 Methadone Toxicology / TDM 09/13/2011
Amedica Biotech Instant Test Cup  
K082898 Methamphetamines Toxicology / TDM 09/13/2011
Amedica Biotech Instant Test Cup  
K082898 Benzodiazepines Toxicology / TDM 09/13/2011
Amedica Biotech Instant Test Cup  
K082898 Barbiturates Toxicology / TDM 09/13/2011
Amedica Biotech Instant Test Cup  
K082898 Tricyclic antidepressants Toxicology / TDM 09/13/2011
Amedica Biotech Instant Test Cup  
K082898 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 09/13/2011
Amedica Biotech Instant Test Cup  
K082898 Oxycodone Toxicology / TDM 09/13/2011
Apex Biotechnology Corp. Autosure Voice Blood Glucose Monitoring System  
K090043 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/13/2011
LifeScan OneTouch Verio Blood Glucose Monitoring System  
K093745 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/13/2011
Fora Care Inc. URIGHT TD-4252 Blood Glucose Monitoring System, model TD-4252  
K101631 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/09/2011
Simple Diagnostics AG-608 Multi Blood Glucose Montoring System  
K102678 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/09/2011
Simple Diagnostics AG-608 Single Blood Glucose Monitoring System  
K102678 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/09/2011
Wondfo Methadone Urine Test  (Cup format)
K112310 Methadone Toxicology / TDM 09/09/2011
Wondfo Methadone Urine Test  (Dip Card format)
K112310 Methadone Toxicology / TDM 09/09/2011
Wondfo Morphine (2000) Urine Test  (Cup format)
K112310 Morphine Toxicology / TDM 09/09/2011
Wondfo Morphine (2000) Urine Test  (Dip Card format)
K112310 Morphine Toxicology / TDM 09/09/2011
Wondfo Nortriptyline Urine Test  (Cup format)
K112395 Tricyclic antidepressants Toxicology / TDM 09/09/2011
Wondfo Nortriptyline Urine Test  (Dip Card format)
K112395 Tricyclic antidepressants Toxicology / TDM 09/09/2011
Wondfo Phencyclidine Urine Test  (Cup format)
K112395 Phencyclidine (PCP) Toxicology / TDM 09/09/2011
Wondfo Phencyclidine Urine Test  (Dip Card format)
K112395 Phencyclidine (PCP) Toxicology / TDM 09/09/2011
Apex Biotechnology Corporation MEG-2 Blood Glucose Monitoring System  
K101204 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/06/2011
Apex Biotechnology Corporation MEG-2 Multi Blood Glucose Monitoring System  
K101204 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/06/2011
Tyson Bio AC100 Blood Glucose Monitoring System  
K101543 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/06/2011
Tyson Bio AC100 Pro Blood Glucose Monitoring System  
K101543 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/06/2011
Tyson Bio AC200 Blood Glucose Monitoring System  
K101543 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/06/2011
Tyson Bio AC200 Pro Blood Glucose Monitoring System  
K101543 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/06/2011
Bionime Corporation GE100 Blood Glucose Monitoring System  
K092052 Glucose monitoring devices (FDA cleared/home use) General Chemistry 09/01/2011
Greenbrier International Inc. Assured Pregnancy Test  
K043443 Urine hCG by visual color comparison tests Endocrinology 08/26/2011
Alere Cholestech LDX  (Whole Blood)
K922612 Alanine aminotransferase (ALT) (SGPT) General Chemistry 08/16/2011
Alere Cholestech LDX  (Whole Blood)
K922612 Triglyceride General Chemistry 08/16/2011
Alere Cholestech LDX  (Whole Blood)
K922612 Aspartate aminotransferase (AST) (SGOT) General Chemistry 08/16/2011
Alere Cholestech LDX  (Whole Blood)
K922612 HDL cholesterol General Chemistry 08/16/2011
Alere Cholestech LDX  (Whole Blood)
K922612 Glucose General Chemistry 08/16/2011
Alere Cholestech LDX  (Whole Blood)
K922612 Cholesterol General Chemistry 08/16/2011
Jant Pharmacal Corporation Accustrip Value+ hCG Urine Pregnancy Test Strip  
K951705 Urine hCG by visual color comparison tests Endocrinology 08/16/2011
MHC Medical Products, LLC. Easy Touch Blood Glucose Monitoring System  
K073492 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/16/2011
Simple Diagnostics AG-6081 Multi Blood Glucose Montoring System  
K101307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/16/2011
Simple Diagnostics AG-6081 Single Blood Glucose Monitoring System  
K101307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/16/2011
Simple Diagnostics AG-6951 Multi Blood Glucose Monitoring System  
K101307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/16/2011
Simple Diagnostics AG-6951 Single Blood Glucose Monitoring System  
K101307 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/16/2011
Zhejiang Orient Gene Biotech Co. Pregnancy One Step Rapid Test (Cassette)  
K103574 Urine hCG by visual color comparison tests Endocrinology 08/12/2011
Zhejiang Orient Gene Biotech Co. Pregnancy One Step Rapid Test (Midstream)  
K103574 Urine hCG by visual color comparison tests Endocrinology 08/12/2011
Zhejiang Orient Gene Biotech Co. Pregnancy One Step Rapid Test (Strip)  
K103574 Urine hCG by visual color comparison tests Endocrinology 08/12/2011
Greenbrier International, Inc EasySCREEN Marijuana Test Strip  
K110182 Cannabinoids (THC) Toxicology / TDM 08/02/2011
Telcare Blood Glucose Monitoring System  
K110571 Glucose monitoring devices (FDA cleared/home use) General Chemistry 08/02/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups  
K091588 Amphetamines Toxicology / TDM 07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups  
K091588 Cannabinoids (THC) Toxicology / TDM 07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups  
K091588 Cocaine metabolites Toxicology / TDM 07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups  
K091588 Opiates Toxicology / TDM 07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups  
K091588 Methadone Toxicology / TDM 07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups  
K091588 Methamphetamines Toxicology / TDM 07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups  
K091588 Benzodiazepines Toxicology / TDM 07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups  
K091588 Barbiturates Toxicology / TDM 07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups  
K091588 Morphine Toxicology / TDM 07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups  
K091588 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/21/2011
UCP Biosciences, Inc. U-Checker Drug Screening Test Cups  
K091588 Oxycodone Toxicology / TDM 07/21/2011
UCP Biosciences, Inc. U-Checker Home Drug Screening Test Cups  
K091588 Phencyclidine (PCP) Toxicology / TDM 07/21/2011
UCP Biosciences, Inc. U-Checker Home Drug Screening Test Cups  
K091588 Tricyclic antidepressants Toxicology / TDM 07/21/2011
Andon Medical Co., Ltd. AG-695 Multi Blood Glucose Monitoring System  
K093755 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/20/2011
Andon Medical Co., Ltd. AG-695 Single Blood Glucose Monitoring System  
K093755 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/20/2011
Andon Medical Co., Ltd. AG-696 Multi Blood Glucose Monitoring System  
K093755 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/20/2011
Andon Medical Co., Ltd. AG-696 Single Blood Glucose Monitoring System  
K093755 Glucose monitoring devices (FDA cleared/home use) General Chemistry 07/20/2011
Heritage House '76 Inc. Quick & Clear hCG Urine Pregancy Tests  (cassette)
K043443 Urine hCG by visual color comparison tests Endocrinology 07/20/2011
Wondfo Amphetamine Urine Test  
K111560 Amphetamines Toxicology / TDM 07/20/2011
Wondfo Oxazepam Urine Test  
K111560 Benzodiazepines Toxicology / TDM 07/20/2011
Wondfo Secobarbital Urine Test  
K111560 Barbiturates Toxicology / TDM 07/20/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)  
K070009 Amphetamines Toxicology / TDM 07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)  
K070009 Cannabinoids (THC) Toxicology / TDM 07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)  
K070009 Phencyclidine (PCP) Toxicology / TDM 07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)  
K070009 Cocaine metabolites Toxicology / TDM 07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)  
K070009 Opiates Toxicology / TDM 07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)  
K070009 Methadone Toxicology / TDM 07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)  
K070009 Methamphetamines Toxicology / TDM 07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)  
K070009 Benzodiazepines Toxicology / TDM 07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)  
K070009 Barbiturates Toxicology / TDM 07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)  
K070009 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/19/2011
Express Diagnostic Int'l Inc DrugCheck Waive RT (Model 9308z)  
K070009 Oxycodone Toxicology / TDM 07/19/2011
Great Lakes Medical Trading Accurate Diagnostics Pregnancy Test Strip  
K951705 Urine hCG by visual color comparison tests Endocrinology 07/14/2011
Independent Medical Co-op. Inc. IMCO Pregnancy Test  
K951705 Urine hCG by visual color comparison tests Endocrinology 07/14/2011
Jant Pharmacal Accutest Value+ hCG Serum/Urine Pregnancy Test Device  
K974009 Urine hCG by visual color comparison tests Endocrinology 07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick ketone Urinalysis 07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick bilirubin Urinalysis 07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick blood Urinalysis 07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick glucose Urinalysis 07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick leukocytes Urinalysis 07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick nitrite Urinalysis 07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick Ph Urinalysis 07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick protein Urinalysis 07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick urobilinogen Urinalysis 07/14/2011
Stanbio Uri-Chek 10SG Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick specific gravity Urinalysis 07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer  
K070929 Urine qualitative dipstick ketone Urinalysis 07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer  
K070929 Urine qualitative dipstick bilirubin Urinalysis 07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer  
K070929 Urine qualitative dipstick blood Urinalysis 07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer  
K070929 Urine qualitative dipstick glucose Urinalysis 07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer  
K070929 Urine qualitative dipstick leukocytes Urinalysis 07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer  
K070929 Urine qualitative dipstick nitrite Urinalysis 07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer  
K070929 Urine qualitative dipstick Ph Urinalysis 07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer  
K070929 Urine qualitative dipstick protein Urinalysis 07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer  
K070929 Urine qualitative dipstick urobilinogen Urinalysis 07/14/2011
Stanbio Uri-Trak 120 Urine Analyzer  
K070929 Urine qualitative dipstick specific gravity Urinalysis 07/14/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test  
K041685 Amphetamines Toxicology / TDM 07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test  
K041685 Cannabinoids (THC) Toxicology / TDM 07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test  
K041685 Phencyclidine (PCP) Toxicology / TDM 07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test  
K041685 Cocaine metabolites Toxicology / TDM 07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test  
K041685 Opiates Toxicology / TDM 07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test  
K041685 Propoxyphene Toxicology / TDM 07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test  
K041685 Benzodiazepines Toxicology / TDM 07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test  
K041685 Barbiturates Toxicology / TDM 07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test  
K041685 Tricyclic antidepressants Toxicology / TDM 07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test  
K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/07/2011
Instant Technologies, Inc. iCassette Dx Drug Screen Test  
K041685 Oxycodone Toxicology / TDM 07/07/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Amphetamines Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Cannabinoids (THC) Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Phencyclidine (PCP) Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Cocaine metabolites Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Opiates Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Methadone Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Methamphetamines Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Benzodiazepines Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Barbiturates Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Morphine Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Tricyclic antidepressants Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Multi-Drug Test Cards  
K091588 Oxycodone Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Amphetamines Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Cannabinoids (THC) Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Phencyclidine (PCP) Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Cocaine metabolites Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Opiates Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Methadone Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Methamphetamines Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Benzodiazepines Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Barbiturates Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Morphine Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Tricyclic antidepressants Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/30/2011
Diagnostic Test Group Clarity Simple Drug Screening Cups  
K110515 Oxycodone Toxicology / TDM 06/30/2011
Fora Care Inc., Fora GD40a/b Blood Glucose Monitoring System  
K101509 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/29/2011
Fora Care Inc., Fora Wisdom GD40a/b Blood Glucose Monitoring System  
K101509 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/29/2011
Fora Care Inc., U-Right TD-4279A/B Blood Glucose Monitoring System  
K101509 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/29/2011
Fora Care Inc., U-Right TD-4279A/B MULTI Blood Glucose Monitoring System  
K101509 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/29/2011
Binax Clearview Advanced Strep A {direct from throat swab} 
K091489 Streptococcus, group A Bacteriology 06/24/2011
EPS Bio Technology Corp EasyMax T1 Pro Self-Monitoring Blood Glucose System  
K102345 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/23/2011
EPS Bio Technology Corp EasyMax T1 Self-Monitoring Blood Glucose System  
K102345 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/23/2011
IND Diagnostic Inc. One Step hCG Urine Pregnancy Test (Strip)  
K110889 hCG, Urine Endocrinology 06/23/2011
Alere NMP22 BladderChek Test {Prescription Home Use} 
K021231 Bladder tumor associated antigen General Immunology 06/22/2011
Alere NMP22 BladderChek Test {Professional Use} 
K021231 Bladder tumor associated antigen General Immunology 06/22/2011
Alere, INRatio 2 PT/INR Monitoring System  (Professional Use)
K072727 Prothrombin time (PT) Hematology 06/22/2011
PSS World Medical, Inc., Quintet AC Blood Glucose Monitoring System  
K092052 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/22/2011
Insight Medical Drug of Abuse Urine Cassette Test  
K100051 Morphine Toxicology / TDM 06/17/2011
Insight Medical Drug of Abuse Urine Cassette Test  
K100051 Oxycodone Toxicology / TDM 06/17/2011
Insight Medical Drug of Abuse Urine Cup Test  
K100051 Morphine Toxicology / TDM 06/17/2011
Insight Medical Drug of Abuse Urine Cup Test  
K100051 Oxycodone Toxicology / TDM 06/17/2011
Instant Technologies, Inc. iScreen Drug of Abuse Urine (Cassette) Test  
K100051 Morphine Toxicology / TDM 06/17/2011
Instant Technologies, Inc. iScreen Drug of Abuse Urine (Cassette) Test  
K100051 Oxycodone Toxicology / TDM 06/17/2011
Instant Technologies, Inc. iScreen Drug of Abuse Urine (Cup) Test  
K100051 Morphine Toxicology / TDM 06/17/2011
Instant Technologies, Inc. iScreen Drug of Abuse Urine (Cup) Test  
K100051 Oxycodone Toxicology / TDM 06/17/2011
Jant Pharmacal AccutestDrug of Abuse Urine (Cassette) Test  
K100051 Morphine Toxicology / TDM 06/17/2011
Jant Pharmacal AccutestDrug of Abuse Urine (Cassette) Test  
K100051 Oxycodone Toxicology / TDM 06/17/2011
Jant Pharmacal AccutestDrug of Abuse Urine (Cup) Test  
K100051 Morphine Toxicology / TDM 06/17/2011
Jant Pharmacal AccutestDrug of Abuse Urine (Cup) Test  
K100051 Oxycodone Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Amphetamines Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Cannabinoids (THC) Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Phencyclidine (PCP) Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Cocaine metabolites Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Opiates Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Methadone Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Methamphetamines Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Benzodiazepines Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Barbiturates Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Tricyclic antidepressants Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/17/2011
PharmTox Rapid Exam Drug Screen Test Cup  
K082898 Oxycodone Toxicology / TDM 06/17/2011
Total Diagnostic Solutions Drug of Abuse Urine (Cassette) Test  
K100051 Morphine Toxicology / TDM 06/17/2011
Total Diagnostic Solutions Drug of Abuse Urine (Cassette) Test  
K100051 Oxycodone Toxicology / TDM 06/17/2011
Total Diagnostic Solutions Drug of Abuse Urine (Cup) Test  
K100051 Morphine Toxicology / TDM 06/17/2011
Total Diagnostic Solutions Drug of Abuse Urine (Cup) Test  
K100051 Oxycodone Toxicology / TDM 06/17/2011
Saless Enterprises New Choice Ovulation Urine Test (Cassette)  
X110078 Luteinizing hormone (LH) Endocrinology 06/14/2011
Simple Diagnostics. Clever Choice Voice+ Blood Glucose Monitoring System  
K102049 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/06/2011
Medline EvenCare G2 Blood Glucose Monitoring System  
K102037 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/03/2011
BTNX Rapid Response U120 Urine Analyzer  
K070929 Urine qualitative dipstick chemistries Urinalysis 06/02/2011
BTNX Rapid Response Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick chemistries Urinalysis 06/02/2011
EPS Bio Technology Corp EG V1 Pro Self-Monitoring Blood Glucose System  
K101037 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/02/2011
EPS Bio Technology Corp EG V1(BL) Self-Monitoring Blood Glucose System  
K101037 Glucose monitoring devices (FDA cleared/home use) General Chemistry 06/02/2011
SCI International, Inc. U-Check Pregnancy Test (Strip Format)  
K062703 Urine hCG by visual color comparison tests Endocrinology 06/02/2011
Wondfo Cannabinoids Urine Test  
K110182 Cannabinoids (THC) Toxicology / TDM 06/02/2011
Proctor and Gamble Clearblue Plus Pregnancy Test  
K110433 Urine hCG by visual color comparison tests Endocrinology 05/13/2011
Saless Enterprises Inc. New Choice Pregnancy Test (cassette)  
K043443 Urine hCG by visual color comparison tests Endocrinology 05/12/2011
Saless Enterprises Inc. Pregnancy Test (strip)  
K043443 Urine hCG by visual color comparison tests Endocrinology 05/12/2011
Saless Enterprises Inc. U-Check Pregnancy Test (cassette)  
K043443 Urine hCG by visual color comparison tests Endocrinology 05/12/2011
Saless Enterprises Inc. U-Check Pregnancy Test (strip)  
K043443 Urine hCG by visual color comparison tests Endocrinology 05/12/2011
Saless Eterprises Inc. Baby Test Pregnancy Test (cassette)  
K043443 Urine hCG by visual color comparison tests Endocrinology 05/12/2011
SMC Direct Inc. RefuAH One Step HCG Urine Test (cassette)  
K043443 Urine hCG by visual color comparison tests Endocrinology 05/12/2011
SMC Direct Inc. RefuAH One Step HCG Urine Test (strip)  
K043443 Urine hCG by visual color comparison tests Endocrinology 05/12/2011
Apex BioTechnology Corp. AutoSure Voice 3 Blood Glucose Monitoring System  
K102481 Glucose monitoring devices (FDA cleared/home use) General Chemistry 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Amphetamines Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Cannabinoids (THC) Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Phencyclidine (PCP) Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Cocaine metabolites Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Opiates Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Methadone Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Methamphetamines Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Benzodiazepines Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Barbiturates Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Tricyclic antidepressants Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/05/2011
Premier Integrity Solutions P/Tox Drug Screen Cup  (OTC)
K052115 Oxycodone Toxicology / TDM 05/05/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Amphetamines Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Cannabinoids (THC) Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Phencyclidine (PCP) Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Cocaine metabolites Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Opiates Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Methadone Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Methamphetamines Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Benzodiazepines Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Barbiturates Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Morphine Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Tricyclic antidepressants Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 04/22/2011
Diagnostic Test Group Clarity Multiple Drug Screen Cups  
K091588 Oxycodone Toxicology / TDM 04/22/2011
Owens & Minor, MediChoice hCG Combi Cassette  
K041728 Urine hCG by visual color comparison tests Endocrinology 04/22/2011
Owens & Minor, MediChoice hCG Urine Cassette  
K041728 Urine hCG by visual color comparison tests Endocrinology 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Amphetamines Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Cannabinoids (THC) Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Phencyclidine (PCP) Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Cocaine metabolites Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Opiates Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Methadone Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Methamphetamines Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Benzodiazepines Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Barbiturates Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Morphine Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Tricyclic antidepressants Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 04/22/2011
UCP Biosciences, Inc. UCP Drug Screening Test Cups  
K110515 Oxycodone Toxicology / TDM 04/22/2011
ProAdvantage by NDC Strep A Test  
K010582 Streptococcus, group A Bacteriology 04/21/2011
Siemens Albustix Reagent Strips for Urinalysis  
X100048 Urine qualitative dipstick protein Urinalysis 04/21/2011
Immunostics Inc. Detector UriStrip IDU-10  
K970250 Urine qualitative dipstick ketone Urinalysis 04/15/2011
Immunostics Inc. Detector UriStrip IDU-10  
K970250 Urine qualitative dipstick bilirubin Urinalysis 04/15/2011
Immunostics Inc. Detector UriStrip IDU-10  
K970250 Urine qualitative dipstick blood Urinalysis 04/15/2011
Immunostics Inc. Detector UriStrip IDU-10  
K970250 Urine qualitative dipstick glucose Urinalysis 04/15/2011
Immunostics Inc. Detector UriStrip IDU-10  
K970250 Urine qualitative dipstick leukocytes Urinalysis 04/15/2011
Immunostics Inc. Detector UriStrip IDU-10  
K970250 Urine qualitative dipstick nitrite Urinalysis 04/15/2011
Immunostics Inc. Detector UriStrip IDU-10  
K970250 Urine qualitative dipstick Ph Urinalysis 04/15/2011
Immunostics Inc. Detector UriStrip IDU-10  
K970250 Urine qualitative dipstick protein Urinalysis 04/15/2011
Immunostics Inc. Detector UriStrip IDU-10  
K970250 Urine qualitative dipstick urobilinogen Urinalysis 04/15/2011
Immunostics Inc. Detector UriStrip IDU-10  
K970250 Urine qualitative dipstick specific gravity Urinalysis 04/15/2011
Mediwatch USA urinewatch Urine Strips  
K061559 Urine qualitative dipstick ketone Urinalysis 04/15/2011
Mediwatch USA urinewatch Urine Strips  
K061559 Urine qualitative dipstick bilirubin Urinalysis 04/15/2011
Mediwatch USA urinewatch Urine Strips  
K061559 Urine qualitative dipstick blood Urinalysis 04/15/2011
Mediwatch USA urinewatch Urine Strips  
K061559 Urine qualitative dipstick glucose Urinalysis 04/15/2011
Mediwatch USA urinewatch Urine Strips  
K061559 Urine qualitative dipstick leukocytes Urinalysis 04/15/2011
Mediwatch USA urinewatch Urine Strips  
K061559 Urine qualitative dipstick nitrite Urinalysis 04/15/2011
Mediwatch USA urinewatch Urine Strips  
K061559 Urine qualitative dipstick Ph Urinalysis 04/15/2011
Mediwatch USA urinewatch Urine Strips  
K061559 Urine qualitative dipstick protein Urinalysis 04/15/2011
Mediwatch USA urinewatch Urine Strips  
K061559 Urine qualitative dipstick urobilinogen Urinalysis 04/15/2011
Mediwatch USA urinewatch Urine Strips  
K061559 Urine qualitative dipstick specific gravity Urinalysis 04/15/2011
Mediwatch USA urinewatch Urine Strips  
K061559 Urine qualitative dipstick ascorbic acid Urinalysis 04/15/2011
Stanbio RELY H. pylori Rapid Test (Whole Blood) {Finger-stick only} 
K024350 Helicobacter pylori antibodies General Immunology 04/07/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Amphetamines Toxicology / TDM 03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Cannabinoids (THC) Toxicology / TDM 03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Phencyclidine (PCP) Toxicology / TDM 03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Cocaine metabolites Toxicology / TDM 03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Opiates Toxicology / TDM 03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Methadone Toxicology / TDM 03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Methamphetamines Toxicology / TDM 03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Benzodiazepines Toxicology / TDM 03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Barbiturates Toxicology / TDM 03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Tricyclic antidepressants Toxicology / TDM 03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 03/24/2011
DRUG DETECTION DEVICES, LTD. Screeners AutoCup Clinical  (OTC)
K052115 Oxycodone Toxicology / TDM 03/24/2011
Mediwatch urinewatch Urine Analyzer  
K070929 Urine qualitative dipstick ketone Urinalysis 03/24/2011
Mediwatch urinewatch Urine Analyzer  
K070929 Urine qualitative dipstick bilirubin Urinalysis 03/24/2011
Mediwatch urinewatch Urine Analyzer  
K070929 Urine qualitative dipstick blood Urinalysis 03/24/2011
Mediwatch urinewatch Urine Analyzer  
K070929 Urine qualitative dipstick glucose Urinalysis 03/24/2011
Mediwatch urinewatch Urine Analyzer  
K070929 Urine qualitative dipstick leukocytes Urinalysis 03/24/2011
Mediwatch urinewatch Urine Analyzer  
K070929 Urine qualitative dipstick nitrite Urinalysis 03/24/2011
Mediwatch urinewatch Urine Analyzer  
K070929 Urine qualitative dipstick Ph Urinalysis 03/24/2011
Mediwatch urinewatch Urine Analyzer  
K070929 Urine qualitative dipstick protein Urinalysis 03/24/2011
Mediwatch urinewatch Urine Analyzer  
K070929 Urine qualitative dipstick urobilinogen Urinalysis 03/24/2011
Mediwatch urinewatch Urine Analyzer  
K070929 Urine qualitative dipstick specific gravity Urinalysis 03/24/2011
OC-Light iFOB Test  
K041297 Fecal occult blood General Chemistry 03/24/2011
Clearview COMPLETE HIV 1/2  (Fingerstick and venous whole blood)
BP050009 HIV-1 and HIV-2 antibodies General Immunology 03/17/2011
Clearview HIV1/2 STAT-PAK  (Fingerstick and venous whole blood)
BP050010 HIV-1 and HIV-2 antibodies General Immunology 03/17/2011
Siemens Combistix Reagent Strips  
K905396 Urine dipstick or tablet analytes, nonautomated Urinalysis 02/25/2011
Siemens Hema-Combistix Reagent Strips  
K905396 Urine dipstick or tablet analytes, nonautomated Urinalysis 02/25/2011
Siemens Hemastix Reagent Strips  
K905396 Urine qualitative dipstick blood Urinalysis 02/25/2011
Siemens Uristix 4 Reagent Strips  
K905396 Urine qualitative dipstick glucose Urinalysis 02/25/2011
Siemens Uristix 4 Reagent Strips  
K905396 Urine qualitative dipstick leukocytes Urinalysis 02/25/2011
Siemens Uristix 4 Reagent Strips  
K905396 Urine qualitative dipstick nitrite Urinalysis 02/25/2011
Siemens Uristix 4 Reagent Strips  
K905396 Urine qualitative dipstick protein Urinalysis 02/25/2011
Siemens Uristix Reagent Strips  
K905396 Urine qualitative dipstick glucose Urinalysis 02/25/2011
Siemens Uristix Reagent Strips  
K905396 Urine qualitative dipstick protein Urinalysis 02/25/2011
TECO DIAGNOSTICS UTI Test Strips  
K100024 Urine qualitative dipstick nitrite Urinalysis 02/25/2011
TECO DIAGNOSTICS UTI Test Strips  
K100024 Leukocyte esterase, urinary Urinalysis 02/25/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer  
K070929 Urine qualitative dipstick ketone Urinalysis 02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer  
K070929 Urine qualitative dipstick bilirubin Urinalysis 02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer  
K070929 Urine qualitative dipstick blood Urinalysis 02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer  
K070929 Urine qualitative dipstick glucose Urinalysis 02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer  
K070929 Urine qualitative dipstick leukocytes Urinalysis 02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer  
K070929 Urine qualitative dipstick nitrite Urinalysis 02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer  
K070929 Urine qualitative dipstick Ph Urinalysis 02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer  
K070929 Urine qualitative dipstick protein Urinalysis 02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer  
K070929 Urine qualitative dipstick urobilinogen Urinalysis 02/14/2011
Germaine Laboratories Inc. AimStrip Urine Analyzer  
K070929 Urine qualitative dipstick specific gravity Urinalysis 02/14/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis  
K970250 Urine qualitative dipstick glucose Urinalysis 02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis  
K970250 Urine qualitative dipstick bilirubin Urinalysis 02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis  
K970250 Urine qualitative dipstick ketone Urinalysis 02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis  
K970250 Urine qualitative dipstick blood Urinalysis 02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis  
K970250 Urine qualitative dipstick leukocytes Urinalysis 02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis  
K970250 Urine qualitative dipstick nitrite Urinalysis 02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis  
K970250 Urine qualitative dipstick Ph Urinalysis 02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis  
K970250 Urine qualitative dipstick protein Urinalysis 02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis  
K970250 Urine qualitative dipstick urobilinogen Urinalysis 02/03/2011
Express Diagnostics International, Inc. UrinCheck HealthScreen-10 Urine Reagent Strips for Urinalysis  
K970250 Urine qualitative dipstick specific gravity Urinalysis 02/03/2011
BTNX Rapid Response Strep A Rapid Test Strips  
K023270 Streptococcus, group A Bacteriology 02/02/2011
hema screen ER  
K102664 Fecal occult blood General Chemistry 02/02/2011
Independent Medical Co-Op, Inc., IMCO Pregnancy Test  
K050741 Urine hCG by visual color comparison tests Endocrinology 02/02/2011
Medi-Weightloss Franchising USA, LLC. Medi-Weightloss Clinics Ketone Test Strips  
K061559 Urine qualitative dipstick ketone Urinalysis 02/02/2011
Express Diagnostics Internationl, Inc. One-Step EARLY PREGNANCY TEST (hCG URINE/SERUM COMBO)  
K964461 Urine hCG by visual color comparison tests Endocrinology 01/24/2011
Great Lakes Medical Trading Accurate Diagnostics Pregnancy Test  
K050741 Urine hCG by visual color comparison tests Endocrinology 01/24/2011
JANT Pharmacal Corp. Accustrip Value+ hCG Serum/Urine Pregnancy Test Strip  
K974060 Urine hCG by visual color comparison tests Endocrinology 01/24/2011
JANT Pharmacal Corp. Accutest Value+ hCG Urine Pregnancy Test Device  
K050741 Urine hCG by visual color comparison tests Endocrinology 01/24/2011
SA Scientific SAS Pregnancy Ultimate  
K990684 Urine hCG by visual color comparison tests Endocrinology 01/21/2011
SA Scientific SAS Ultimate hCG  
K990684 Urine hCG by visual color comparison tests Endocrinology 01/21/2011
Temcare Medical Design & Manufacturing, Inc. Solstice TB 100 Blood Glucose Monitoring System  
K073492 Glucose monitoring devices (FDA cleared/home use) General Chemistry 01/21/2011
SCI International Inc, New Choice Ovulation Predictor (Cassette)  
X100049 Ovulation test (LH) By visual color comparison Endocrinology 01/18/2011
SCI International Inc, New Choice Ovulation Predictor (Midstream)  
X100049 Ovulation test (LH) By visual color comparison Endocrinology 01/18/2011
BTNX, Inc. Rapid Response Influenza A Test Cassette  
K041441 Influenza A Virology 01/10/2011
BTNX, Inc. Rapid Response Influenza B Test Cassette  
K041439 Influenza B Virology 01/10/2011
BTNX Inc. Rapid Response RSV Test  
K022845 Respiratory syncytial virus Virology 01/03/2011
Jant Pharmacal Accutest Value+ Pregnancy Combo Test (Cassette)  
K984077 Urine hCG by visual color comparison tests Endocrinology 12/29/2010
Saless Enterprises Inc, New Choice Ovulation Predictor (Cassette)  
X100053 Ovulation test (LH) By visual color comparison Endocrinology 12/29/2010
Saless Enterprises Inc, New Choice Ovulation Predictor (Midstream)  
X100053 Ovulation test (LH) By visual color comparison Endocrinology 12/29/2010
Stanbio Laboratories, Stanbio alpha One-Step Pregnancy Combo Test (Cassette)  
K984077 Urine hCG by visual color comparison tests Endocrinology 12/29/2010
Advantage Pro by NDC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick ketone Urinalysis 12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick bilirubin Urinalysis 12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick blood Urinalysis 12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick glucose Urinalysis 12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick leukocytes Urinalysis 12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick nitrite Urinalysis 12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick Ph Urinalysis 12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick protein Urinalysis 12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick urobilinogen Urinalysis 12/21/2010
Advantage Pro by NDC Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick specific gravity Urinalysis 12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick ketone Urinalysis 12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick bilirubin Urinalysis 12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick blood Urinalysis 12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick glucose Urinalysis 12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick leukocytes Urinalysis 12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick nitrite Urinalysis 12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick Ph Urinalysis 12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick protein Urinalysis 12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick urobilinogen Urinalysis 12/21/2010
Cliawaived Inc. Urinalysis Reagent Strips  
K970250 Urine qualitative dipstick specific gravity Urinalysis 12/21/2010
Acceava Strep A Test  
K023766 Streptococcus, group A Bacteriology 12/17/2010
Siemens Hematest Reagent Tablets  (Pre-amendment device)
X100047 Fecal occult blood General Chemistry 12/17/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick ketone Urinalysis 12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick bilirubin Urinalysis 12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick blood Urinalysis 12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick glucose Urinalysis 12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick leukocytes Urinalysis 12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick nitrite Urinalysis 12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips  
K061559 Urine qualitative dipstick Ph Urinalysis 12/03/2010
BTNX Inc., Rapid Response Urinalysis Reagent Strips  
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