|
|
| Document |
Test System Name Analyte |
Analyte Specialty |
Effective Date |
| 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 |
| 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 |
| American Screening Corporation Discover Multi-Panel Drug Test Cups |
| 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 |
| American Screening Corporation Discover Multi-Panel Drug Test Cups |
| K123863 |
Benzodiazepines |
Toxicology / TDM |
02/27/2013 |
| American Screening Corporation Discover Multi-Panel Drug Test Cups |
| K123863 |
Barbiturates |
Toxicology / TDM |
02/27/2013 |
| American Screening Corporation Discover Multi-Panel Drug Test Cups |
| 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 |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
02/22/2013 |
| 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 |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/22/2013 |
| Cliawaived Inc. Auto Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Ph |
Urinalysis |
02/22/2013 |
| 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 |
| EGENS One Step HCG Urine Pregnancy Test Kit (Strip) |
| 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 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| K122633 |
Cannabinoids (THC) |
Toxicology / TDM |
02/08/2013 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| K122633 |
Phencyclidine (PCP) |
Toxicology / TDM |
02/08/2013 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| K122633 |
Cocaine Metabolites |
Toxicology / TDM |
02/08/2013 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| K122633 |
Methadone |
Toxicology / TDM |
02/08/2013 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| K122633 |
Propoxyphene |
Toxicology / TDM |
02/08/2013 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| K122633 |
Methamphetamines |
Toxicology / TDM |
02/08/2013 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| K122633 |
Benzodiazepines |
Toxicology / TDM |
02/08/2013 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| K122633 |
Barbiturates |
Toxicology / TDM |
02/08/2013 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| K122633 |
Morphine |
Toxicology / TDM |
02/08/2013 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| K122633 |
Tricyclic Antidepressants |
Toxicology / TDM |
02/08/2013 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| K122633 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
02/08/2013 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| K122633 |
Oxycodone |
Toxicology / TDM |
02/08/2013 |
| Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format) |
| 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 |
| CLIAwaived, Inc. Rapid Drug Test Cup |
| K052115 |
Methamphetamines |
Toxicology / TDM |
02/08/2013 |
| CLIAwaived, Inc. Rapid Drug Test Cup |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
02/08/2013 |
| CLIAwaived, Inc. Rapid Drug Test Cup |
| K052115 |
Barbiturates |
Toxicology / TDM |
02/08/2013 |
| CLIAwaived, Inc. Rapid Drug Test Cup |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
02/08/2013 |
| CLIAwaived, Inc. Rapid Drug Test Cup |
| 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 |
| Clinical Reference Laboratory, Inc. Intelligent Transport Cup |
| 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 |
| Clinical Reference Laboratory, Inc. Intelligent Transport Cup |
| K052115 |
Methamphetamines |
Toxicology / TDM |
02/08/2013 |
| Clinical Reference Laboratory, Inc. Intelligent Transport Cup |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
02/08/2013 |
| Clinical Reference Laboratory, Inc. Intelligent Transport Cup |
| K052115 |
Barbiturates |
Toxicology / TDM |
02/08/2013 |
| Clinical Reference Laboratory, Inc. Intelligent Transport Cup |
| 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 |
| Noble Medical Inc. NOBLE 1 Step Cup |
| K052115 |
Methamphetamines |
Toxicology / TDM |
02/08/2013 |
| Noble Medical Inc. NOBLE 1 Step Cup |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
02/08/2013 |
| Noble Medical Inc. NOBLE 1 Step Cup |
| K052115 |
Barbiturates |
Toxicology / TDM |
02/08/2013 |
| Noble Medical Inc. NOBLE 1 Step Cup |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
02/08/2013 |
| Noble Medical Inc. NOBLE 1 Step Cup |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
02/08/2013 |
| Noble Medical Inc. NOBLE 1 Step Cup |
| K052115 |
Oxycodone |
Toxicology / TDM |
02/08/2013 |
| Premier Integrity Solutions P/Tox Drug Screen Cup |
| K052115 |
Amphetamines |
Toxicology / TDM |
02/08/2013 |
| Premier Integrity Solutions P/Tox Drug Screen Cup |
| K052115 |
Cannabinoids (THC) |
Toxicology / TDM |
02/08/2013 |
| Premier Integrity Solutions P/Tox Drug Screen Cup |
| K052115 |
Phencyclidine (PCP) |
Toxicology / TDM |
02/08/2013 |
| Premier Integrity Solutions P/Tox Drug Screen Cup |
| K052115 |
Cocaine Metabolites |
Toxicology / TDM |
02/08/2013 |
| Premier Integrity Solutions P/Tox Drug Screen Cup |
| K052115 |
Opiates |
Toxicology / TDM |
02/08/2013 |
| Premier Integrity Solutions P/Tox Drug Screen Cup |
| K052115 |
Methadone |
Toxicology / TDM |
02/08/2013 |
| Premier Integrity Solutions P/Tox Drug Screen Cup |
| K052115 |
Methamphetamines |
Toxicology / TDM |
02/08/2013 |
| Premier Integrity Solutions P/Tox Drug Screen Cup |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
02/08/2013 |
| Premier Integrity Solutions P/Tox Drug Screen Cup |
| K052115 |
Barbiturates |
Toxicology / TDM |
02/08/2013 |
| Premier Integrity Solutions P/Tox Drug Screen Cup |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
02/08/2013 |
| Premier Integrity Solutions P/Tox Drug Screen Cup |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
02/08/2013 |
| Premier Integrity Solutions P/Tox Drug Screen Cup |
| K052115 |
Oxycodone |
Toxicology / TDM |
02/08/2013 |
| US Diagnostics ProScreen Drugs of Abuse Cup |
| K052115 |
Amphetamines |
Toxicology / TDM |
02/08/2013 |
| US Diagnostics ProScreen Drugs of Abuse Cup |
| K052115 |
Cannabinoids (THC) |
Toxicology / TDM |
02/08/2013 |
| US Diagnostics ProScreen Drugs of Abuse Cup |
| K052115 |
Phencyclidine (PCP) |
Toxicology / TDM |
02/08/2013 |
| US Diagnostics ProScreen Drugs of Abuse Cup |
| K052115 |
Cocaine Metabolites |
Toxicology / TDM |
02/08/2013 |
| US Diagnostics ProScreen Drugs of Abuse Cup |
| K052115 |
Opiates |
Toxicology / TDM |
02/08/2013 |
| US Diagnostics ProScreen Drugs of Abuse Cup |
| K052115 |
Methadone |
Toxicology / TDM |
02/08/2013 |
| US Diagnostics ProScreen Drugs of Abuse Cup |
| K052115 |
Methamphetamines |
Toxicology / TDM |
02/08/2013 |
| US Diagnostics ProScreen Drugs of Abuse Cup |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
02/08/2013 |
| US Diagnostics ProScreen Drugs of Abuse Cup |
| K052115 |
Barbiturates |
Toxicology / TDM |
02/08/2013 |
| US Diagnostics ProScreen Drugs of Abuse Cup |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
02/08/2013 |
| US Diagnostics ProScreen Drugs of Abuse Cup |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
02/08/2013 |
| US Diagnostics ProScreen Drugs of Abuse Cup |
| K052115 |
Oxycodone |
Toxicology / TDM |
02/08/2013 |
| Micro Distributing II, Ltd STAT CUP One Step Drug TEST Cup (Cup format) |
| K122904 |
Amphetamines |
Toxicology / TDM |
02/05/2013 |
| Micro Distributing II, Ltd STAT CUP One Step Drug TEST Cup (Cup format) |
| K122904 |
Cannabinoids (THC) |
Toxicology / TDM |
02/05/2013 |
| Micro Distributing II, Ltd STAT CUP One Step Drug TEST Cup (Cup format) |
| K122904 |
Benzodiazepines |
Toxicology / TDM |
02/05/2013 |
| Micro Distributing II, Ltd STAT CUP One Step Drug TEST Cup (Cup format) |
| K122904 |
Barbiturates |
Toxicology / TDM |
02/05/2013 |
| Micro Distributing II, Ltd STAT CUP One Step Drug TEST Cup (Cup format) |
| K122904 |
Oxycodone |
Toxicology / TDM |
02/05/2013 |
| Micro Distributing II, Ltd STAT DIP One Step Multi Drug Test Panel (Dip Card format) |
| K122904 |
Amphetamines |
Toxicology / TDM |
02/05/2013 |
| Micro Distributing II, Ltd STAT DIP One Step Multi Drug Test Panel (Dip Card format) |
| K122904 |
Cannabinoids (THC) |
Toxicology / TDM |
02/05/2013 |
| Micro Distributing II, Ltd STAT DIP One Step Multi Drug Test Panel (Dip Card format) |
| K122904 |
Benzodiazepines |
Toxicology / TDM |
02/05/2013 |
| Micro Distributing II, Ltd STAT DIP One Step Multi Drug Test Panel (Dip Card format) |
| K122904 |
Barbiturates |
Toxicology / TDM |
02/05/2013 |
| Micro Distributing II, Ltd STAT DIP One Step Multi Drug Test Panel (Dip Card format) |
| K122904 |
Oxycodone |
Toxicology / TDM |
02/05/2013 |
| 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 |
| US Diagnostics Inc. UScreen Drugs of Abuse Cup |
| K122904 |
Cannabinoids (THC) |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Cup |
| K122904 |
Benzodiazepines |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Cup |
| K122904 |
Barbiturates |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Cup |
| K122904 |
Oxycodone |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Cup |
| K121166 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Cup |
| K121166 |
Cocaine Metabolites |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Cup |
| K121166 |
Opiates |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Cup |
| K121166 |
Methadone |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Cup |
| K121166 |
Methamphetamines |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Cup |
| K121166 |
Morphine |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Cup |
| K121166 |
Tricyclic Antidepressants |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Cup |
| K121166 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K121166 |
Phencyclidine (PCP) |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K121166 |
Cocaine Metabolites |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K121166 |
Opiates |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K121166 |
Methadone |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K121166 |
Methamphetamines |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K121166 |
Morphine |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K121166 |
Tricyclic Antidepressants |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K121166 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K122904 |
Amphetamines |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K122904 |
Cannabinoids (THC) |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K122904 |
Benzodiazepines |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K122904 |
Barbiturates |
Toxicology / TDM |
01/30/2013 |
| US Diagnostics Inc. UScreen Drugs of Abuse Dip Card |
| K122904 |
Oxycodone |
Toxicology / TDM |
01/30/2013 |
| General Electric Company GE200 Blood Glucose Monitoring System |
| K123008 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/29/2013 |
| Henry Schein Urispec Plus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
01/29/2013 |
| Henry Schein Urispec Plus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
01/29/2013 |
| Henry Schein Urispec Plus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Blood |
Urinalysis |
01/29/2013 |
| Henry Schein Urispec Plus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
01/29/2013 |
| Henry Schein Urispec Plus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
01/29/2013 |
| Henry Schein Urispec Plus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
01/29/2013 |
| Henry Schein Urispec Plus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Ph |
Urinalysis |
01/29/2013 |
| Henry Schein Urispec Plus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Protein |
Urinalysis |
01/29/2013 |
| Henry Schein Urispec Plus Urine Analyzer |
| K061742 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
01/29/2013 |
| Henry Schein Urispec Plus Urine Analyzer |
| 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 (Prescription Use Only) |
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 |
| K051321 |
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 |
| K072500 |
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) |
| K112236 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test (MDMA/Methylenedioxymethamphetamine) (Cup format) |
| K112236 |
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) |
| K112236 |
Morphine |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test (MOP/Morphine) (Dip Card format) |
| K112236 |
Morphine |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test (MTD/Methadone) (Cup format) |
| K112310 |
Methadone |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test (MTD/Methadone) (Dip Card format) |
| K112310 |
Methadone |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test (PCP/Phencyclidine) (Cup format) |
| K112395 |
Phencyclidine (PCP) |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test (PCP/Phencyclidine) (Dip Card format) |
| K112395 |
Phencyclidine (PCP) |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test Cassette |
| K110182 |
Cannabinoids (THC) |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test Cassette AMP/Amphetamine |
| K111560 |
Amphetamines |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test Morphine (2000) (Cup format) |
| K112310 |
Morphine |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test Morphine (2000) (Dip Card format) |
| K112310 |
Morphine |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test Nortriptyline (Cup format) |
| K112395 |
Tricyclic Antidepressants |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test Nortriptyline (Dip Card format) |
| K112395 |
Tricyclic Antidepressants |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test Oxazepam Cassette |
| K111560 |
Benzodiazepines |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test Oxazepam Strip |
| K111560 |
Benzodiazepines |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test Secobarbital Cassette |
| K111560 |
Barbiturates |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test Secobarbital Strip |
| K111560 |
Barbiturates |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test Strip |
| K110182 |
Cannabinoids (THC) |
Toxicology / TDM |
05/29/2012 |
| BTNX Inc Rapid Response X-Press Drug Test Strip AMP/Amphetamine |
| K111560 |
Amphetamines |
Toxicology / TDM |
05/29/2012 |
| BTNX Rapid Response One Step HCG Urine Pregnancy Test |
| K043443 |
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 (Prescription Use Only) |
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 |
| K022538 |
Albumin, Urinary |
General Chemistry |
02/16/2012 |
| Sekisui Diagnostics, LLC, OSOM TRICHOMONAS RAPID TEST |
| K033864 |
Trichomonas |
Parasitology |
02/16/2012 |
| Sekisui Diagnostics, LLC, OSOM ULTRA STREP A |
| K992658 |
Streptococcus, Group A |
Bacteriology |
02/16/2012 |
| Sekisui Diagnostics, LLC, SIGNIFY HCG URINE TEST |
| K974159 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
02/16/2012 |
| Sekisui Diagnostics, LLC, SIGNIFY MONO TEST (For whole blood) |
| K972231 |
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 |
| K022538 |
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 (Prescription Use Only) |
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) |
| K032027 |
Aspartate Aminotransferase (AST) (SGOT) |
General Chemistry |
08/16/2011 |
| Alere Cholestech LDX (Whole Blood) |
| K991834 |
Alanine Aminotransferase (ALT) (SGPT) |
General Chemistry |
08/16/2011 |
| Alere Cholestech LDX (Whole Blood) |
| K932727 |
Glucose |
General Chemistry |
08/16/2011 |
| Alere Cholestech LDX (Whole Blood) |
| K922612 |
Triglyceride |
General Chemistry |
08/16/2011 |
| Alere Cholestech LDX (Whole Blood) |
| K922612 |
HDL Cholesterol |
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 |
| K992257 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/25/2011 |
| Siemens Uristix 4 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
02/25/2011 |
| Siemens Uristix 4 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
02/25/2011 |
| Siemens Uristix 4 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Protein |
Urinalysis |
02/25/2011 |
| Siemens Uristix Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
02/25/2011 |
| Siemens Uristix Reagent Strips |
| K992257 |
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 |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
12/03/2010 |
| BTNX Inc., Rapid Response Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
12/03/2010 |
| BTNX Inc., Rapid Response Urinalysis Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Ph |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (10 parameters) |
| K993850 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (2 parameters) |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (2 parameters) |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (4 parameters) |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (4 parameters) |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (4 parameters) |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
12/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips (4 parameters) |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
12/03/2010 |
| EPS Bio Technology Corp. EasyMax L Self-Monitoring Blood Glucose System |
| K101457 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/22/2010 |
| Centralcheck iFOBT Complete Fecal Occult Blood Test |
| K063693 |
Fecal Occult Blood |
General Chemistry |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Glucose & Protein Urinalysis Reagent Strips (2 Parameters) |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Glucose & Protein Urinalysis Reagent Strips (2 Parameters) |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Glucose, Protein, Nitrite & Leukocytes Urinalysis Reagent Strips (4 Parameters) |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Glucose, Protein, Nitrite & Leukocytes Urinalysis Reagent Strips (4 Parameters) |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Glucose, Protein, Nitrite & Leukocytes Urinalysis Reagent Strips (4 Parameters) |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Glucose, Protein, Nitrite & Leukocytes Urinalysis Reagent Strips (4 Parameters) |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Blood |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Ph |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Protein |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
11/16/2010 |
| Great Lakes Medical Trading Accurate Diagnostics Urinalysis Reagent strips (10 Parameters) |
| K993850 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
11/16/2010 |
| SCI International Inc. Baby Test Pregnancy Test (For Home Use) (Cassette) |
| K023638 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
11/16/2010 |
| SCI International Inc. U-Check Pregnancy Test (For Home Use) (Cassette) |
| K023638 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
11/16/2010 |
| Cole Taylor Marketing, Inc. CTMI Combo Pregnancy |
| K981165 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
10/18/2010 |
| Saless Enterprises Inc. Baby Test Preagnancy Test (For Home Use) (Cassette) |
| K023638 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
10/18/2010 |
| Saless Enterprises Inc. New Choice Pregnancy Test (For Home Use) (Cassette) |
| K023638 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
10/18/2010 |
| Saless Enterprises Inc. U-Check Pregnancy Test (For Home Use) (Cassette( |
| K023638 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Amphetamines |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Cannabinoids (THC) |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Phencyclidine (PCP) |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Cocaine Metabolites |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Opiates |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Methadone |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Methamphetamines |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Benzodiazepines |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Barbiturates |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Morphine |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Tricyclic Antidepressants |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Drug Screening Test Cards |
| K091588 |
Oxycodone |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Amphetamines |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Cannabinoids (THC) |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Phencyclidine (PCP) |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Cocaine Metabolites |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Opiates |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Methadone |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Methamphetamines |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Benzodiazepines |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Barbiturates |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Morphine |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Tricyclic Antidepressants |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
10/18/2010 |
| UCP Biosciences, Inc. Multiple Drug Screen Cups |
| K091588 |
Oxycodone |
Toxicology / TDM |
10/18/2010 |
| SCI International Inc. New Choice Pregnancy Test |
| K023638 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
10/07/2010 |
| Accutest H. pylori Rapid Test-Serum (Dip Strip) {Jant Pharmacal} |
| K024360 |
Helicobacter Pylori |
Bacteriology |
10/04/2010 |
| American IVD Biotechnology Services Inc. FOB/CRC Advanced+ |
| K100031 |
Fecal Occult Blood |
General Chemistry |
10/04/2010 |
| BTNX Inc. Rapid Response Fecal Immunochemical Test (FIT) |
| K100031 |
Fecal Occult Blood |
General Chemistry |
10/04/2010 |
| BTNX, Inc. Strep A Rapid Test |
| K023270 |
Streptococcus, Group A |
Bacteriology |
10/04/2010 |
| Consult Diagnostics Mononucleosis Cassette (Whole Blood) |
| K961024 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
10/04/2010 |
| Jant Pharmacal Accutest VALUE+ Pregnancy Urine Test (Cassette) |
| K984076 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
10/04/2010 |
| NexScreen LLC, NexScreen Cup |
| K082898 |
Amphetamines |
Toxicology / TDM |
10/04/2010 |
| NexScreen LLC, NexScreen Cup |
| K082898 |
Cannabinoids (THC) |
Toxicology / TDM |
10/04/2010 |
| NexScreen LLC, NexScreen Cup |
| K082898 |
Phencyclidine (PCP) |
Toxicology / TDM |
10/04/2010 |
| NexScreen LLC, NexScreen Cup |
| K082898 |
Cocaine Metabolites |
Toxicology / TDM |
10/04/2010 |
| NexScreen LLC, NexScreen Cup |
| K082898 |
Opiates |
Toxicology / TDM |
10/04/2010 |
| NexScreen LLC, NexScreen Cup |
| K082898 |
Methadone |
Toxicology / TDM |
10/04/2010 |
| NexScreen LLC, NexScreen Cup |
| K082898 |
Methamphetamines |
Toxicology / TDM |
10/04/2010 |
| NexScreen LLC, NexScreen Cup |
| K082898 |
Benzodiazepines |
Toxicology / TDM |
10/04/2010 |
| NexScreen LLC, NexScreen Cup |
| K082898 |
Barbiturates |
Toxicology / TDM |
10/04/2010 |
| NexScreen LLC, NexScreen Cup |
| K082898 |
Tricyclic Antidepressants |
Toxicology / TDM |
10/04/2010 |
| NexScreen LLC, NexScreen Cup |
| K082898 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
10/04/2010 |
| NexScreen LLC, NexScreen Cup |
| K082898 |
Oxycodone |
Toxicology / TDM |
10/04/2010 |
| Siemens Labstix Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
10/04/2010 |
| Siemens Labstix Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Blood |
Urinalysis |
10/04/2010 |
| Siemens Labstix Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
10/04/2010 |
| Siemens Labstix Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ph |
Urinalysis |
10/04/2010 |
| Siemens Labstix Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Protein |
Urinalysis |
10/04/2010 |
| Stanbio Laboratory, Stanbio alpha One-Step Pregnancy Urine Test (Cassette) |
| K984076 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
10/04/2010 |
| Tyson Bioresearch, Inc. EZ-Smart Plus Blood Glucose Monitoring System |
| K052818 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/04/2010 |
| Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
09/14/2010 |
| Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
09/14/2010 |
| Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
09/14/2010 |
| Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
09/14/2010 |
| Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
09/14/2010 |
| Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
09/14/2010 |
| Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
09/14/2010 |
| Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
09/14/2010 |
| Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
09/14/2010 |
| Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
09/14/2010 |
| Confirm Biosciences Drugconfirm instant multi-drug test kit, Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
09/14/2010 |
| CTMI Strep A Rapid Test Strip {Cole Taylor Marketing Inc. Strep A} |
| K010582 |
Streptococcus, Group A |
Bacteriology |
09/14/2010 |
| Jant Pharmacal Corporation ACCUTEST Drug Test Cup |
| K082898 |
Amphetamines |
Toxicology / TDM |
09/14/2010 |
| Jant Pharmacal Corporation ACCUTEST Drug Test Cup |
| K082898 |
Cannabinoids (THC) |
Toxicology / TDM |
09/14/2010 |
| Jant Pharmacal Corporation ACCUTEST Drug Test Cup |
| K082898 |
Phencyclidine (PCP) |
Toxicology / TDM |
09/14/2010 |
| Jant Pharmacal Corporation ACCUTEST Drug Test Cup |
| K082898 |
Cocaine Metabolites |
Toxicology / TDM |
09/14/2010 |
| Jant Pharmacal Corporation ACCUTEST Drug Test Cup |
| K082898 |
Opiates |
Toxicology / TDM |
09/14/2010 |
| Jant Pharmacal Corporation ACCUTEST Drug Test Cup |
| K082898 |
Methadone |
Toxicology / TDM |
09/14/2010 |
| Jant Pharmacal Corporation ACCUTEST Drug Test Cup |
| K082898 |
Methamphetamines |
Toxicology / TDM |
09/14/2010 |
| Jant Pharmacal Corporation ACCUTEST Drug Test Cup |
| K082898 |
Benzodiazepines |
Toxicology / TDM |
09/14/2010 |
| Jant Pharmacal Corporation ACCUTEST Drug Test Cup |
| K082898 |
Barbiturates |
Toxicology / TDM |
09/14/2010 |
| Jant Pharmacal Corporation ACCUTEST Drug Test Cup |
| K082898 |
Tricyclic Antidepressants |
Toxicology / TDM |
09/14/2010 |
| Jant Pharmacal Corporation ACCUTEST Drug Test Cup |
| K082898 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
09/14/2010 |
| Jant Pharmacal Corporation ACCUTEST Drug Test Cup |
| K082898 |
Oxycodone |
Toxicology / TDM |
09/14/2010 |
| Amedica Biotech AmediCheck Instant Test Cup |
| K082898 |
Amphetamines |
Toxicology / TDM |
09/08/2010 |
| Amedica Biotech AmediCheck Instant Test Cup |
| K082898 |
Cannabinoids (THC) |
Toxicology / TDM |
09/08/2010 |
| Amedica Biotech AmediCheck Instant Test Cup |
| K082898 |
Phencyclidine (PCP) |
Toxicology / TDM |
09/08/2010 |
| Amedica Biotech AmediCheck Instant Test Cup |
| K082898 |
Cocaine Metabolites |
Toxicology / TDM |
09/08/2010 |
| Amedica Biotech AmediCheck Instant Test Cup |
| K082898 |
Opiates |
Toxicology / TDM |
09/08/2010 |
| Amedica Biotech AmediCheck Instant Test Cup |
| K082898 |
Methadone |
Toxicology / TDM |
09/08/2010 |
| Amedica Biotech AmediCheck Instant Test Cup |
| K082898 |
Methamphetamines |
Toxicology / TDM |
09/08/2010 |
| Amedica Biotech AmediCheck Instant Test Cup |
| K082898 |
Benzodiazepines |
Toxicology / TDM |
09/08/2010 |
| Amedica Biotech AmediCheck Instant Test Cup |
| K082898 |
Barbiturates |
Toxicology / TDM |
09/08/2010 |
| Amedica Biotech AmediCheck Instant Test Cup |
| K082898 |
Tricyclic Antidepressants |
Toxicology / TDM |
09/08/2010 |
| Amedica Biotech AmediCheck Instant Test Cup |
| K082898 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
09/08/2010 |
| Amedica Biotech AmediCheck Instant Test Cup |
| K082898 |
Oxycodone |
Toxicology / TDM |
09/08/2010 |
| McKesson Medi-Lab Performance 10SG Urine Reagent Strips |
| K970250 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
09/08/2010 |
| McKesson Medi-Lab Performance 10SG Urine Reagent Strips |
| K970250 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
09/08/2010 |
| McKesson Medi-Lab Performance 10SG Urine Reagent Strips |
| K970250 |
Urine Qualitative Dipstick Blood |
Urinalysis |
09/08/2010 |
| McKesson Medi-Lab Performance 10SG Urine Reagent Strips |
| K970250 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
09/08/2010 |
| McKesson Medi-Lab Performance 10SG Urine Reagent Strips |
| K970250 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
09/08/2010 |
| McKesson Medi-Lab Performance 10SG Urine Reagent Strips |
| K970250 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
09/08/2010 |
| McKesson Medi-Lab Performance 10SG Urine Reagent Strips |
| K970250 |
Urine Qualitative Dipstick Ph |
Urinalysis |
09/08/2010 |
| McKesson Medi-Lab Performance 10SG Urine Reagent Strips |
| K970250 |
Urine Qualitative Dipstick Protein |
Urinalysis |
09/08/2010 |
| McKesson Medi-Lab Performance 10SG Urine Reagent Strips |
| K970250 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
09/08/2010 |
| McKesson Medi-Lab Performance 10SG Urine Reagent Strips |
| K970250 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
09/08/2010 |
| Siemens ICTOTEST Reagent Tablets (Urine, qualitative bilirubin) |
| X100013 |
Urine Dipstick Or Tablet Analytes, Nonautomated |
Urinalysis |
09/08/2010 |
| Bionime Corporation, Rightest GM250 Blood Glucose Monitoring System |
| K092052 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/01/2010 |
| Bionime Corporation, Rightest GM260 Blood Glucose Monitoring System |
| K092052 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/01/2010 |
| i-Sens Inc. DirecTest Blood Glucose Monitoring System |
| K083468 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/01/2010 |
| Quidel RapidVue hCG test -Urine |
| K102175 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
09/01/2010 |
| PSS Consult Diagnostics Strep A Dipstick |
| K023766 |
Streptococcus, Group A |
Bacteriology |
08/19/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Amphetamines |
Toxicology / TDM |
08/18/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Cannabinoids (THC) |
Toxicology / TDM |
08/18/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Phencyclidine (PCP) |
Toxicology / TDM |
08/18/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Cocaine Metabolites |
Toxicology / TDM |
08/18/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Opiates |
Toxicology / TDM |
08/18/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Methadone |
Toxicology / TDM |
08/18/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Methamphetamines |
Toxicology / TDM |
08/18/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Benzodiazepines |
Toxicology / TDM |
08/18/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Barbiturates |
Toxicology / TDM |
08/18/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Morphine |
Toxicology / TDM |
08/18/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Tricyclic Antidepressants |
Toxicology / TDM |
08/18/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
08/18/2010 |
| American Screening Corporation Reveal Multi-Drug Testing Cups |
| K091588 |
Oxycodone |
Toxicology / TDM |
08/18/2010 |
| Apex BioTechnology Corp. AutoSure Voice II Blood Glucose Monitoring System |
| K102037 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/18/2010 |
| PSS Consult Diagnostics Strep A Dipstick |
| K010582 |
Streptococcus, Group A |
Bacteriology |
08/18/2010 |
| Taidoc Technology Corporation ECHO TD-3227 Dual Blood Pressure/Blood Glucose Monitoring System |
| K092875 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/18/2010 |
| TeenSaver Diagnostics, Inc TeenSavers Home Drug Test |
| K082898 |
Amphetamines |
Toxicology / TDM |
08/18/2010 |
| TeenSaver Diagnostics, Inc TeenSavers Home Drug Test |
| K082898 |
Cannabinoids (THC) |
Toxicology / TDM |
08/18/2010 |
| TeenSaver Diagnostics, Inc TeenSavers Home Drug Test |
| K082898 |
Phencyclidine (PCP) |
Toxicology / TDM |
08/18/2010 |
| TeenSaver Diagnostics, Inc TeenSavers Home Drug Test |
| K082898 |
Cocaine Metabolites |
Toxicology / TDM |
08/18/2010 |
| TeenSaver Diagnostics, Inc TeenSavers Home Drug Test |
| K082898 |
Opiates |
Toxicology / TDM |
08/18/2010 |
| TeenSaver Diagnostics, Inc TeenSavers Home Drug Test |
| K082898 |
Methadone |
Toxicology / TDM |
08/18/2010 |
| TeenSaver Diagnostics, Inc TeenSavers Home Drug Test |
| K082898 |
Methamphetamines |
Toxicology / TDM |
08/18/2010 |
| TeenSaver Diagnostics, Inc TeenSavers Home Drug Test |
| K082898 |
Benzodiazepines |
Toxicology / TDM |
08/18/2010 |
| TeenSaver Diagnostics, Inc TeenSavers Home Drug Test |
| K082898 |
Barbiturates |
Toxicology / TDM |
08/18/2010 |
| TeenSaver Diagnostics, Inc TeenSavers Home Drug Test |
| K082898 |
Tricyclic Antidepressants |
Toxicology / TDM |
08/18/2010 |
| TeenSaver Diagnostics, Inc TeenSavers Home Drug Test |
| K082898 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
08/18/2010 |
| TeenSaver Diagnostics, Inc TeenSavers Home Drug Test |
| K082898 |
Oxycodone |
Toxicology / TDM |
08/18/2010 |
| OMNIS Health Voice Blood Glucose Monitoring System |
| K073137 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
08/09/2010 |
| IND Diagnostic, Inc. One Step Fecal Occult Blood Test |
| K100031 |
Fecal Occult Blood |
General Chemistry |
07/28/2010 |
| Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cassette Test |
| K100051 |
Morphine |
Toxicology / TDM |
07/19/2010 |
| Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cassette Test |
| K100051 |
Oxycodone |
Toxicology / TDM |
07/19/2010 |
| Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cup Test |
| K100051 |
Morphine |
Toxicology / TDM |
07/19/2010 |
| Alfa Scientific Designs, Inc. Instant-View Drug of Abuse Urine Cup Test |
| K100051 |
Oxycodone |
Toxicology / TDM |
07/19/2010 |
| Andon Medical Co., Ltd. AG-608 Blood Glucose Monitoring System |
| K093262 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/19/2010 |
| Andon Medical Co., Ltd. AG-610 Blood Glucose Monitoring System |
| K093262 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/19/2010 |
| Fora Care Inc. FORA G30a Blood Glucose Monitoring System |
| K100732 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/19/2010 |
| Fora Care Inc. FORA G90 Perform Blood Glucose Monitoring System |
| K100405 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/19/2010 |
| Consult Diagnostics Immunochemical Fecal Occult Blood Test (iFOBT) |
| K060463 |
Fecal Occult Blood |
General Chemistry |
07/08/2010 |
| EPS Bio Technology Corp. EasyPlus mini R9N Self Monitoring Blood Glucose System |
| K101457 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/08/2010 |
| Princeton BioMeditech BioSign Immunochemical Fecal Occult Blood Test (iFOBT) |
| K100817 |
Fecal Occult Blood |
General Chemistry |
07/08/2010 |
| ProAdvantage by NDC Fecal Occult Blood Test Device |
| K902360 |
Fecal Occult Blood |
General Chemistry |
07/08/2010 |
| Insight Medical Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
07/04/2010 |
| Insight Medical Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
07/04/2010 |
| Insight Medical Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/04/2010 |
| Insight Medical Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
07/04/2010 |
| Insight Medical Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
07/04/2010 |
| Insight Medical Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
07/04/2010 |
| Insight Medical Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
07/04/2010 |
| Insight Medical Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
07/04/2010 |
| Insight Medical Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
07/04/2010 |
| Insight Medical Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
07/04/2010 |
| Insight Medical Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
07/04/2010 |
| Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
07/04/2010 |
| Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
07/04/2010 |
| Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/04/2010 |
| Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
07/04/2010 |
| Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
07/04/2010 |
| Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
07/04/2010 |
| Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
07/04/2010 |
| Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
07/04/2010 |
| Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
07/04/2010 |
| Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
07/04/2010 |
| Micro Distributing II, Ltd Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
07/04/2010 |
| Millenium Laboratories Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
07/04/2010 |
| Millenium Laboratories Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
07/04/2010 |
| Millenium Laboratories Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/04/2010 |
| Millenium Laboratories Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
07/04/2010 |
| Millenium Laboratories Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
07/04/2010 |
| Millenium Laboratories Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
07/04/2010 |
| Millenium Laboratories Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
07/04/2010 |
| Millenium Laboratories Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
07/04/2010 |
| Millenium Laboratories Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
07/04/2010 |
| Millenium Laboratories Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
07/04/2010 |
| Millenium Laboratories Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
07/04/2010 |
| On the Spot Drug Testing Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
07/04/2010 |
| On the Spot Drug Testing Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
07/04/2010 |
| On the Spot Drug Testing Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/04/2010 |
| On the Spot Drug Testing Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
07/04/2010 |
| On the Spot Drug Testing Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
07/04/2010 |
| On the Spot Drug Testing Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
07/04/2010 |
| On the Spot Drug Testing Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
07/04/2010 |
| On the Spot Drug Testing Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
07/04/2010 |
| On the Spot Drug Testing Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
07/04/2010 |
| On the Spot Drug Testing Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
07/04/2010 |
| On the Spot Drug Testing Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
07/04/2010 |
| Physicians' Test Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
07/04/2010 |
| Physicians' Test Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
07/04/2010 |
| Physicians' Test Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/04/2010 |
| Physicians' Test Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
07/04/2010 |
| Physicians' Test Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
07/04/2010 |
| Physicians' Test Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
07/04/2010 |
| Physicians' Test Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
07/04/2010 |
| Physicians' Test Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
07/04/2010 |
| Physicians' Test Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
07/04/2010 |
| Physicians' Test Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
07/04/2010 |
| Physicians' Test Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
07/04/2010 |
| QuikTest USA, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
07/04/2010 |
| QuikTest USA, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
07/04/2010 |
| QuikTest USA, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/04/2010 |
| QuikTest USA, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
07/04/2010 |
| QuikTest USA, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
07/04/2010 |
| QuikTest USA, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
07/04/2010 |
| QuikTest USA, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
07/04/2010 |
| QuikTest USA, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
07/04/2010 |
| QuikTest USA, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
07/04/2010 |
| QuikTest USA, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
07/04/2010 |
| QuikTest USA, Inc. Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
07/04/2010 |
| Screen Tox Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
07/04/2010 |
| Screen Tox Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
07/04/2010 |
| Screen Tox Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/04/2010 |
| Screen Tox Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
07/04/2010 |
| Screen Tox Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
07/04/2010 |
| Screen Tox Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
07/04/2010 |
| Screen Tox Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
07/04/2010 |
| Screen Tox Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
07/04/2010 |
| Screen Tox Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
07/04/2010 |
| Screen Tox Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
07/04/2010 |
| Screen Tox Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
07/04/2010 |
| Total Diagnostic Solutions Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
07/04/2010 |
| Total Diagnostic Solutions Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
07/04/2010 |
| Total Diagnostic Solutions Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/04/2010 |
| Total Diagnostic Solutions Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
07/04/2010 |
| Total Diagnostic Solutions Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
07/04/2010 |
| Total Diagnostic Solutions Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
07/04/2010 |
| Total Diagnostic Solutions Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
07/04/2010 |
| Total Diagnostic Solutions Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
07/04/2010 |
| Total Diagnostic Solutions Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
07/04/2010 |
| Total Diagnostic Solutions Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
07/04/2010 |
| Total Diagnostic Solutions Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
07/04/2010 |
| Tyson Bioresearch, Inc. TysonBio CONTROL Blood Glucose Monitoring System |
| K052818 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
07/04/2010 |
| Ameditech, Inc ImmuTest Drug Screen Cup |
| K052115 |
Amphetamines |
Toxicology / TDM |
07/01/2010 |
| Ameditech, Inc ImmuTest Drug Screen Cup |
| K052115 |
Cannabinoids (THC) |
Toxicology / TDM |
07/01/2010 |
| Ameditech, Inc ImmuTest Drug Screen Cup |
| K052115 |
Phencyclidine (PCP) |
Toxicology / TDM |
07/01/2010 |
| Ameditech, Inc ImmuTest Drug Screen Cup |
| K052115 |
Cocaine Metabolites |
Toxicology / TDM |
07/01/2010 |
| Ameditech, Inc ImmuTest Drug Screen Cup |
| K052115 |
Opiates |
Toxicology / TDM |
07/01/2010 |
| Ameditech, Inc ImmuTest Drug Screen Cup |
| K052115 |
Methadone |
Toxicology / TDM |
07/01/2010 |
| Ameditech, Inc ImmuTest Drug Screen Cup |
| K052115 |
Methamphetamines |
Toxicology / TDM |
07/01/2010 |
| Ameditech, Inc ImmuTest Drug Screen Cup |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
07/01/2010 |
| Ameditech, Inc ImmuTest Drug Screen Cup |
| K052115 |
Barbiturates |
Toxicology / TDM |
07/01/2010 |
| Ameditech, Inc ImmuTest Drug Screen Cup |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
07/01/2010 |
| Ameditech, Inc ImmuTest Drug Screen Cup |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
07/01/2010 |
| Ameditech, Inc ImmuTest Drug Screen Cup |
| K052115 |
Oxycodone |
Toxicology / TDM |
07/01/2010 |
| sanofi aventis BGStar Blood Glucose Monitoring System |
| K072413 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/27/2010 |
| Allmedicus AGM-4000 GlucoDr Auto Blood Glucose Monitoring System |
| K083628 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/24/2010 |
| Bionime USA Corporation Rightest Blood Glucose Monitoring System, Model GM550 |
| K092052 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/24/2010 |
| GenExel-Sein, Inc., DUO-CARE Blood Glucose and Blood Pressure Monitoring System |
| K080853 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/24/2010 |
| Abbott FreeStyle 3 Blood Glucose Monitoring System |
| K092638 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/18/2010 |
| Abbott FreeStyle 5 Blood Glucose Monitoring System |
| K092638 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/18/2010 |
| Abbott FreeStyle Flash Blood Glucose Monitoring System |
| K092638 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/18/2010 |
| Abbott FreeStyle Freedom Blood Glucose Monitoring System |
| K092638 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/18/2010 |
| Biotron Diagnostics inc., Dr. G Glucose Meter Glucose Monitoring System |
| K052818 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/18/2010 |
| Siemens MULTISTIX PRO 10LS |
| K992257 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX PRO 10LS |
| K992257 |
Urine Qualitative Dipstick Blood |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX PRO 10LS |
| K992257 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX PRO 10LS |
| K992257 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX PRO 10LS |
| K992257 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX PRO 10LS |
| K992257 |
Urine Qualitative Dipstick Ph |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX PRO 10LS |
| K992257 |
Urine Qualitative Dipstick Protein |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX PRO 10LS |
| K992257 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX PRO 10LS |
| K992257 |
Urine Qualitative Dipstick Creatinine |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX Pro 11 |
| K992257 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX Pro 11 |
| K992257 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX Pro 11 |
| K992257 |
Urine Qualitative Dipstick Blood |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX Pro 11 |
| K992257 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX Pro 11 |
| K992257 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX Pro 11 |
| K992257 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX Pro 11 |
| K992257 |
Urine Qualitative Dipstick Ph |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX Pro 11 |
| K992257 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX Pro 11 |
| K992257 |
Urine Qualitative Dipstick Creatinine |
Urinalysis |
06/18/2010 |
| Siemens MULTISTIX Pro 11 |
| K992257 |
Urinary Protein, Qualitative |
Urinalysis |
06/18/2010 |
| Standard Diagnostics USA SmartLink GOLD Blood Glucose Monitoring System |
| K100398 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/18/2010 |
| Saless Enterprises, Inc. New Choice Urinary Tract Infection Test Strips |
| K063295 |
Nitrite, Urine |
General Chemistry |
06/14/2010 |
| Saless Enterprises, Inc. New Choice Urinary Tract Infection Test Strips |
| K063295 |
Leukocyte Esterase, Urinary |
Urinalysis |
06/14/2010 |
| Express Diagnostic International, Inc. Urine Pregnancy Cassette Test |
| K936031 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/04/2010 |
| Express Diagnostic International, Inc. Urine Pregnancy Dipstick Test |
| K964536 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
06/04/2010 |
| Aventir Biotech ForSure Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
06/03/2010 |
| Aventir Biotech ForSure Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
06/03/2010 |
| Aventir Biotech ForSure Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Blood |
Urinalysis |
06/03/2010 |
| Aventir Biotech ForSure Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
06/03/2010 |
| Aventir Biotech ForSure Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
06/03/2010 |
| Aventir Biotech ForSure Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
06/03/2010 |
| Aventir Biotech ForSure Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
06/03/2010 |
| Aventir Biotech ForSure Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
06/03/2010 |
| Aventir Biotech ForSure Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
06/03/2010 |
| Aventir Biotech ForSure Urine Reagent Strips |
| K051727 |
pH, Urine |
General Chemistry |
06/03/2010 |
| Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer |
| K070929 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer |
| K070929 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer |
| K070929 |
Urine Qualitative Dipstick Blood |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer |
| K070929 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer |
| K070929 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer |
| K070929 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer |
| K070929 |
Urine Qualitative Dipstick Ph |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer |
| K070929 |
Urine Qualitative Dipstick Protein |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer |
| K070929 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CT-120 Urine Strip Analyzer |
| K070929 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Ph |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
06/03/2010 |
| Cole-Taylor Marketing Inc. CTMI Urine Reagent Strips Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
06/03/2010 |
| Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
06/03/2010 |
| Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
06/03/2010 |
| Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
06/03/2010 |
| Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
06/03/2010 |
| Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
06/03/2010 |
| Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
06/03/2010 |
| Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Ph |
Urinalysis |
06/03/2010 |
| Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
06/03/2010 |
| Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
06/03/2010 |
| Fisher HealthCare, Fisherbrand 10SG Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
06/03/2010 |
| HealthPia USA LLC, GlucoPhone Blood Glucose Monitoring System |
| K091168 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
06/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
06/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Blood |
Urinalysis |
06/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
06/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
06/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
06/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Ph |
Urinalysis |
06/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Protein |
Urinalysis |
06/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
06/03/2010 |
| Independent Medical Co-op, Inc. IMCO Urine Screen Urine Reagent Strips |
| K061559 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
06/03/2010 |
| Liberty Medical, Liberty Next Generation Blood Glucose Monitoring System |
| K073573 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Amphetamines |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Cannabinoids (THC) |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Cocaine Metabolites |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Opiates |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Methadone |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Methamphetamines |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Benzodiazepines |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Barbiturates |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Morphine |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Tricyclic Antidepressants |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc Multiple Drug Screen Cups |
| K091588 |
Oxycodone |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Amphetamines |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Cannabinoids (THC) |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Phencyclidine (PCP) |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Cocaine Metabolites |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Opiates |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Methadone |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Methamphetamines |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Benzodiazepines |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Barbiturates |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Morphine |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Tricyclic Antidepressants |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
06/03/2010 |
| MedDirect, Inc ProXam Drug Test Cards |
| K091588 |
Oxycodone |
Toxicology / TDM |
06/03/2010 |
| Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strip |
| K051727 |
pH, Urine |
General Chemistry |
06/03/2010 |
| Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
06/03/2010 |
| Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
06/03/2010 |
| Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Blood |
Urinalysis |
06/03/2010 |
| Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
06/03/2010 |
| Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
06/03/2010 |
| Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
06/03/2010 |
| Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Protein |
Urinalysis |
06/03/2010 |
| Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
06/03/2010 |
| Syntron Bioresearch, Inc. Urige 10 Urine Reagent Strips |
| K051727 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
06/03/2010 |
| Target, up& up Blood Glucose meter Monitoring System |
| K073573 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
06/03/2010 |
| Immunostics, Inc., hema-screen STAT |
| K905782 |
Fecal Occult Blood |
General Chemistry |
05/20/2010 |
| SpermCheck Fertility |
| K100341 |
Semen |
Hematology |
05/20/2010 |
| Fora Care Inc. FORA V20 Blood Glucose Monitoring System |
| K100406 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/13/2010 |
| Home Aide Diagnostics, Inc., Easy Talk Talking Blood Glucose Monitoring System |
| K100560 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/13/2010 |
| Omnis Health Victory Blood Glucose Monitoring System |
| K083628 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/13/2010 |
| Tyson Bioresearch, Inc., TysonBio Evolve Blood Glucose Monitoring System |
| K073492 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/13/2010 |
| Tyson Bioresearch, Inc., TysonBio TB100 Blood Glucose Monitoring System |
| K073492 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/13/2010 |
| Fora Care Inc. Fora G31a /TD-4256A Blood Glucose Monitoring System |
| K094005 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/10/2010 |
| Fora Care Inc. Fora G31b /TD-4256B Blood Glucose Monitoring System |
| K094005 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/10/2010 |
| Siemens MULTISTIX 10 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 10 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 10 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Blood |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 10 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 10 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 10 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 10 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ph |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 10 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 10 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 10 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 5 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Blood |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 5 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 5 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 5 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 5 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 7 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 7 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Blood |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 7 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 7 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 7 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 7 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ph |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 7 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 8 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 8 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Blood |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 8 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 8 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 8 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 8 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ph |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 8 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 8 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Blood |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ph |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Blood |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ph |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX 9 SG Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Blood |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Ph |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Protein |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
05/10/2010 |
| Siemens MULTISTIX Reagent Strips |
| K992257 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
05/10/2010 |
| US Diagnostics ProScreen Drugs of Abuse Cup (OTC) |
| K052115 |
Amphetamines |
Toxicology / TDM |
05/10/2010 |
| US Diagnostics ProScreen Drugs of Abuse Cup (OTC) |
| K052115 |
Cannabinoids (THC) |
Toxicology / TDM |
05/10/2010 |
| US Diagnostics ProScreen Drugs of Abuse Cup (OTC) |
| K052115 |
Phencyclidine (PCP) |
Toxicology / TDM |
05/10/2010 |
| US Diagnostics ProScreen Drugs of Abuse Cup (OTC) |
| K052115 |
Cocaine Metabolites |
Toxicology / TDM |
05/10/2010 |
| US Diagnostics ProScreen Drugs of Abuse Cup (OTC) |
| K052115 |
Opiates |
Toxicology / TDM |
05/10/2010 |
| US Diagnostics ProScreen Drugs of Abuse Cup (OTC) |
| K052115 |
Methadone |
Toxicology / TDM |
05/10/2010 |
| US Diagnostics ProScreen Drugs of Abuse Cup (OTC) |
| K052115 |
Methamphetamines |
Toxicology / TDM |
05/10/2010 |
| US Diagnostics ProScreen Drugs of Abuse Cup (OTC) |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
05/10/2010 |
| US Diagnostics ProScreen Drugs of Abuse Cup (OTC) |
| K052115 |
Barbiturates |
Toxicology / TDM |
05/10/2010 |
| US Diagnostics ProScreen Drugs of Abuse Cup (OTC) |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
05/10/2010 |
| US Diagnostics ProScreen Drugs of Abuse Cup (OTC) |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
05/10/2010 |
| US Diagnostics ProScreen Drugs of Abuse Cup (OTC) |
| K052115 |
Oxycodone |
Toxicology / TDM |
05/10/2010 |
| Instant Technologies, iCup Dx Drug Screen Cup |
| K052115 |
Amphetamines |
Toxicology / TDM |
05/06/2010 |
| Instant Technologies, iCup Dx Drug Screen Cup |
| K052115 |
Cannabinoids (THC) |
Toxicology / TDM |
05/06/2010 |
| Instant Technologies, iCup Dx Drug Screen Cup |
| K052115 |
Phencyclidine (PCP) |
Toxicology / TDM |
05/06/2010 |
| Instant Technologies, iCup Dx Drug Screen Cup |
| K052115 |
Cocaine Metabolites |
Toxicology / TDM |
05/06/2010 |
| Instant Technologies, iCup Dx Drug Screen Cup |
| K052115 |
Opiates |
Toxicology / TDM |
05/06/2010 |
| Instant Technologies, iCup Dx Drug Screen Cup |
| K052115 |
Methadone |
Toxicology / TDM |
05/06/2010 |
| Instant Technologies, iCup Dx Drug Screen Cup |
| K052115 |
Methamphetamines |
Toxicology / TDM |
05/06/2010 |
| Instant Technologies, iCup Dx Drug Screen Cup |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
05/06/2010 |
| Instant Technologies, iCup Dx Drug Screen Cup |
| K052115 |
Barbiturates |
Toxicology / TDM |
05/06/2010 |
| Instant Technologies, iCup Dx Drug Screen Cup |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
05/06/2010 |
| Instant Technologies, iCup Dx Drug Screen Cup |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
05/06/2010 |
| Instant Technologies, iCup Dx Drug Screen Cup |
| K052115 |
Oxycodone |
Toxicology / TDM |
05/06/2010 |
| Alliance International Co., Ltd., A-Check DS-A Blood Glucose Monitoring System |
| K082965 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
05/04/2010 |
| Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
05/03/2010 |
| Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
05/03/2010 |
| Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
05/03/2010 |
| Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
05/03/2010 |
| Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
05/03/2010 |
| Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
05/03/2010 |
| Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
05/03/2010 |
| Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
05/03/2010 |
| Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
05/03/2010 |
| Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
05/03/2010 |
| Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
05/03/2010 |
| Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
05/03/2010 |
| Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
05/03/2010 |
| Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
05/03/2010 |
| Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
05/03/2010 |
| Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
05/03/2010 |
| Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
05/03/2010 |
| Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
05/03/2010 |
| Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
05/03/2010 |
| Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
05/03/2010 |
| Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
05/03/2010 |
| Instant Technologies, Inc. iScreen Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
05/03/2010 |
| Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test |
| K063545 |
Amphetamines |
Toxicology / TDM |
05/03/2010 |
| Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test |
| K063545 |
Cannabinoids (THC) |
Toxicology / TDM |
05/03/2010 |
| Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test |
| K063545 |
Phencyclidine (PCP) |
Toxicology / TDM |
05/03/2010 |
| Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test |
| K063545 |
Cocaine Metabolites |
Toxicology / TDM |
05/03/2010 |
| Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test |
| K063545 |
Methadone |
Toxicology / TDM |
05/03/2010 |
| Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test |
| K063545 |
Methamphetamines |
Toxicology / TDM |
05/03/2010 |
| Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test |
| K063545 |
Benzodiazepines |
Toxicology / TDM |
05/03/2010 |
| Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test |
| K063545 |
Barbiturates |
Toxicology / TDM |
05/03/2010 |
| Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test |
| K063545 |
Morphine |
Toxicology / TDM |
05/03/2010 |
| Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test |
| K063545 |
Tricyclic Antidepressants |
Toxicology / TDM |
05/03/2010 |
| Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test |
| K063545 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
05/03/2010 |
| Diabetic Supply of Suncoast, Inc., ADVOCATE REDI-CODE DASH Blood Glucose Monitoring System |
| K093940 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Amphetamines |
Toxicology / TDM |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Cannabinoids (THC) |
Toxicology / TDM |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Phencyclidine (PCP) |
Toxicology / TDM |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Cocaine Metabolites |
Toxicology / TDM |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Opiates |
Toxicology / TDM |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Methadone |
Toxicology / TDM |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Methamphetamines |
Toxicology / TDM |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Benzodiazepines |
Toxicology / TDM |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Barbiturates |
Toxicology / TDM |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Morphine |
Toxicology / TDM |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Tricyclic Antidepressants |
Toxicology / TDM |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
04/30/2010 |
| Express Diagnostics International Inc. DrugCheck Waive Multiple Drug Screen Cups |
| K091588 |
Oxycodone |
Toxicology / TDM |
04/30/2010 |
| BTNX Inc. Rapid Response LH Ovulation Test |
| X100002 |
Ovulation Test (LH) By Visual Color Comparison |
Endocrinology |
04/21/2010 |
| CLIAwaived, Inc. Rapid Drug Test Cup (OTC) |
| K052115 |
Amphetamines |
Toxicology / TDM |
04/21/2010 |
| CLIAwaived, Inc. Rapid Drug Test Cup (OTC) |
| K052115 |
Cannabinoids (THC) |
Toxicology / TDM |
04/21/2010 |
| CLIAwaived, Inc. Rapid Drug Test Cup (OTC) |
| K052115 |
Phencyclidine (PCP) |
Toxicology / TDM |
04/21/2010 |
| CLIAwaived, Inc. Rapid Drug Test Cup (OTC) |
| K052115 |
Cocaine Metabolites |
Toxicology / TDM |
04/21/2010 |
| CLIAwaived, Inc. Rapid Drug Test Cup (OTC) |
| K052115 |
Opiates |
Toxicology / TDM |
04/21/2010 |
| CLIAwaived, Inc. Rapid Drug Test Cup (OTC) |
| K052115 |
Methadone |
Toxicology / TDM |
04/21/2010 |
| CLIAwaived, Inc. Rapid Drug Test Cup (OTC) |
| K052115 |
Methamphetamines |
Toxicology / TDM |
04/21/2010 |
| CLIAwaived, Inc. Rapid Drug Test Cup (OTC) |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
04/21/2010 |
| CLIAwaived, Inc. Rapid Drug Test Cup (OTC) |
| K052115 |
Barbiturates |
Toxicology / TDM |
04/21/2010 |
| CLIAwaived, Inc. Rapid Drug Test Cup (OTC) |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
04/21/2010 |
| CLIAwaived, Inc. Rapid Drug Test Cup (OTC) |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
04/21/2010 |
| CLIAwaived, Inc. Rapid Drug Test Cup (OTC) |
| K052115 |
Oxycodone |
Toxicology / TDM |
04/21/2010 |
| Express Diagnostics, DRUGCHECK Waive Cup |
| K052115 |
Amphetamines |
Toxicology / TDM |
04/21/2010 |
| Express Diagnostics, DRUGCHECK Waive Cup |
| K052115 |
Cannabinoids (THC) |
Toxicology / TDM |
04/21/2010 |
| Express Diagnostics, DRUGCHECK Waive Cup |
| K052115 |
Phencyclidine (PCP) |
Toxicology / TDM |
04/21/2010 |
| Express Diagnostics, DRUGCHECK Waive Cup |
| K052115 |
Cocaine Metabolites |
Toxicology / TDM |
04/21/2010 |
| Express Diagnostics, DRUGCHECK Waive Cup |
| K052115 |
Opiates |
Toxicology / TDM |
04/21/2010 |
| Express Diagnostics, DRUGCHECK Waive Cup |
| K052115 |
Methadone |
Toxicology / TDM |
04/21/2010 |
| Express Diagnostics, DRUGCHECK Waive Cup |
| K052115 |
Methamphetamines |
Toxicology / TDM |
04/21/2010 |
| Express Diagnostics, DRUGCHECK Waive Cup |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
04/21/2010 |
| Express Diagnostics, DRUGCHECK Waive Cup |
| K052115 |
Barbiturates |
Toxicology / TDM |
04/21/2010 |
| Express Diagnostics, DRUGCHECK Waive Cup |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
04/21/2010 |
| Express Diagnostics, DRUGCHECK Waive Cup |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
04/21/2010 |
| Express Diagnostics, DRUGCHECK Waive Cup |
| K052115 |
Oxycodone |
Toxicology / TDM |
04/21/2010 |
| Fora Care Inc. U-Right TD-3252 Blood Glucose plus Blood Pressure Monitoring System |
| K091555 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/21/2010 |
| Life Systems Inc. Odyssey Blood Glucose Monitoring System |
| K062799 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/21/2010 |
| Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup |
| K052115 |
Amphetamines |
Toxicology / TDM |
04/21/2010 |
| Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup |
| K052115 |
Cannabinoids (THC) |
Toxicology / TDM |
04/21/2010 |
| Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup |
| K052115 |
Phencyclidine (PCP) |
Toxicology / TDM |
04/21/2010 |
| Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup |
| K052115 |
Cocaine Metabolites |
Toxicology / TDM |
04/21/2010 |
| Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup |
| K052115 |
Opiates |
Toxicology / TDM |
04/21/2010 |
| Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup |
| K052115 |
Methadone |
Toxicology / TDM |
04/21/2010 |
| Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup |
| K052115 |
Methamphetamines |
Toxicology / TDM |
04/21/2010 |
| Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
04/21/2010 |
| Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup |
| K052115 |
Barbiturates |
Toxicology / TDM |
04/21/2010 |
| Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
04/21/2010 |
| Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
04/21/2010 |
| Millennium Laboratories Clinical Supply, Inc Multi-Drug Pain Med Screen Cup |
| K052115 |
Oxycodone |
Toxicology / TDM |
04/21/2010 |
| Noble Medical Inc. NOBLE 1 Step Cup (OTC) |
| K052115 |
Amphetamines |
Toxicology / TDM |
04/21/2010 |
| Noble Medical Inc. NOBLE 1 Step Cup (OTC) |
| K052115 |
Cannabinoids (THC) |
Toxicology / TDM |
04/21/2010 |
| Noble Medical Inc. NOBLE 1 Step Cup (OTC) |
| K052115 |
Phencyclidine (PCP) |
Toxicology / TDM |
04/21/2010 |
| Noble Medical Inc. NOBLE 1 Step Cup (OTC) |
| K052115 |
Cocaine Metabolites |
Toxicology / TDM |
04/21/2010 |
| Noble Medical Inc. NOBLE 1 Step Cup (OTC) |
| K052115 |
Opiates |
Toxicology / TDM |
04/21/2010 |
| Noble Medical Inc. NOBLE 1 Step Cup (OTC) |
| K052115 |
Methadone |
Toxicology / TDM |
04/21/2010 |
| Noble Medical Inc. NOBLE 1 Step Cup (OTC) |
| K052115 |
Methamphetamines |
Toxicology / TDM |
04/21/2010 |
| Noble Medical Inc. NOBLE 1 Step Cup (OTC) |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
04/21/2010 |
| Noble Medical Inc. NOBLE 1 Step Cup (OTC) |
| K052115 |
Barbiturates |
Toxicology / TDM |
04/21/2010 |
| Noble Medical Inc. NOBLE 1 Step Cup (OTC) |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
04/21/2010 |
| Noble Medical Inc. NOBLE 1 Step Cup (OTC) |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
04/21/2010 |
| Noble Medical Inc. NOBLE 1 Step Cup (OTC) |
| K052115 |
Oxycodone |
Toxicology / TDM |
04/21/2010 |
| Redwood Toxicology Laboratory, Inc Reditest Freedom Cup |
| K052115 |
Amphetamines |
Toxicology / TDM |
04/21/2010 |
| Redwood Toxicology Laboratory, Inc Reditest Freedom Cup |
| K052115 |
Cannabinoids (THC) |
Toxicology / TDM |
04/21/2010 |
| Redwood Toxicology Laboratory, Inc Reditest Freedom Cup |
| K052115 |
Phencyclidine (PCP) |
Toxicology / TDM |
04/21/2010 |
| Redwood Toxicology Laboratory, Inc Reditest Freedom Cup |
| K052115 |
Cocaine Metabolites |
Toxicology / TDM |
04/21/2010 |
| Redwood Toxicology Laboratory, Inc Reditest Freedom Cup |
| K052115 |
Opiates |
Toxicology / TDM |
04/21/2010 |
| Redwood Toxicology Laboratory, Inc Reditest Freedom Cup |
| K052115 |
Methadone |
Toxicology / TDM |
04/21/2010 |
| Redwood Toxicology Laboratory, Inc Reditest Freedom Cup |
| K052115 |
Methamphetamines |
Toxicology / TDM |
04/21/2010 |
| Redwood Toxicology Laboratory, Inc Reditest Freedom Cup |
| K052115 |
Benzodiazepines |
Toxicology / TDM |
04/21/2010 |
| Redwood Toxicology Laboratory, Inc Reditest Freedom Cup |
| K052115 |
Barbiturates |
Toxicology / TDM |
04/21/2010 |
| Redwood Toxicology Laboratory, Inc Reditest Freedom Cup |
| K052115 |
Tricyclic Antidepressants |
Toxicology / TDM |
04/21/2010 |
| Redwood Toxicology Laboratory, Inc Reditest Freedom Cup |
| K052115 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
04/21/2010 |
| Redwood Toxicology Laboratory, Inc Reditest Freedom Cup |
| K052115 |
Oxycodone |
Toxicology / TDM |
04/21/2010 |
| CoaguSense Self-Test Prothrombin Time/INR Monitoring System {Prescription Home Use} |
| K093243 |
Prothrombin Time (PT) |
Hematology |
04/15/2010 |
| Common Sense Ltd. VS-Sense Test (Qualitative) |
| K091287 |
Vaginal pH |
General Chemistry |
04/15/2010 |
| Fora Care Inc. FORA V30/TD-4242 Blood Glucose Monitoring System |
| K093635 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/15/2010 |
| Fora Care U-Right TD-4238 Blood Glucose Monitoring System |
| K092902 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/15/2010 |
| Fora Care U-Right TD-4246 Blood Glucose Monitoring System |
| K092902 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/15/2010 |
| Hummingbird Medical, Inc., Oracle Blood Glucose Monitoring System |
| K091815 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/15/2010 |
| Progressive Health Supply and Source Corporation, Smartest Persona Blood Glucose Monitoring System |
| K100701 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/15/2010 |
| Simple Diagnostics CLEVER CHOICE Auto-code Pro Blood Glucose Monitoring System |
| K093506 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/15/2010 |
| Gemco Medical EasyMax V Self-Monitoring Blood Glucose System |
| K092894 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
04/07/2010 |
| McKesson Medi-Lab Performance Infectious Mononucleosis Test (For whole blood) |
| K961024 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
03/31/2010 |
| Simple Diagnostics CLEVER CHOICE mini Blood Glucose Monitoring System |
| K093941 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/31/2010 |
| BioSense Medical, SoloV2 Audible Blood Glucose Management System |
| K093764 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/25/2010 |
| Gluco Perfect, L.L.C., Perfect 3 Blood Glucose Monitoring System |
| K091815 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/09/2010 |
| NDC Inc., Pro Advantage by NDC Urine Pregnancy Test Strip |
| K993203 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/09/2010 |
| Roche Diagnostics CoaguChek XS Plus PST System |
| K092940 |
Prothrombin Time (PT) |
Hematology |
03/09/2010 |
| BTNX, Inc Rapid Response Thyroid Stimulating Hormone (TSH) Test Cassette (Whole Blood) |
| K990658 |
Thyroid Stimulating Hormone (TSH) |
Endocrinology |
03/04/2010 |
| Home Diagnostics Grace IV Prestige IQ Blood Glucose Monitoring System |
| K010403 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/04/2010 |
| Links Medical Products Inc. microdot Blood Glucose Monitoring System |
| K070524 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/04/2010 |
| Aventir Biotech LLC, FORSURE TSH test (Whole Blood) |
| K990658 |
Thyroid Stimulating Hormone (TSH) |
Endocrinology |
03/02/2010 |
| Home Health UK, Ltd. One Step HCG Urine Pregnancy Test (Cassette Style) |
| K062703 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/02/2010 |
| Home Health UK, Ltd. One Step HCG Urine Pregnancy Test (Midstream) |
| K062703 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/02/2010 |
| Home Health UK, Ltd. One Step HCG Urine Pregnancy Test (Strip Style) |
| K062703 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
03/02/2010 |
| Nova Biomedical Nova Max Plus Glucose and B-Ketone Monitoring System |
| K091547 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/02/2010 |
| Nova Biomedical Nova Max Plus Glucose and B-Ketone Monitoring System |
| K091547 |
Ketone, Blood |
General Chemistry |
03/02/2010 |
| Tyson Bioresearch Inc. TysonBio Superb Blood Glucose Monitoring System |
| K072854 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/02/2010 |
| Tyson Bioresearch Inc. TysonBio Vigor Blood Glucose Monitoring System |
| K072854 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/02/2010 |
| Diabetic Supply of Suncoast, Inc., Advocate Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, TD-3223E |
| K093592 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/01/2010 |
| Fora Care Inc. Fora G70/TD-4273 Blood Glucose Monitoring System |
| K093005 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/01/2010 |
| Fora Care Inc. Fora G71a / TD-4274 Blood Glucose Monitoring System |
| K093712 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/01/2010 |
| Fora Care Inc. Fora G72/TD-4264 Blood Glucose Monitoring System |
| K093005 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
03/01/2010 |
| Inverness Medical Clearview iFOBT Complete Fecal Occult Blood Test |
| K063693 |
Fecal Occult Blood |
General Chemistry |
03/01/2010 |
| Standard Diagnostics USA SD Check Gold Blood Glucose Monitoring System |
| K082683 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/18/2010 |
| OK Biotech Co., Ltd. OKmeter Match Blood Glucose Monitoring System |
| K090609 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/16/2010 |
| Bayer Didget Blood Glucose Monitoring System |
| K090628 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
02/01/2010 |
| Care Diagnostic Clarity IFOB Test |
| K052598 |
Fecal Occult Blood |
General Chemistry |
01/26/2010 |
| Heritage House '76 Inc., The Precious Feet Midstream Pregnancy Test |
| K974059 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
01/26/2010 |
| ARJ Pylo-Plus Urease Test {H. pylori detection} |
| K052708 |
Helicobacter Pylori |
Bacteriology |
01/20/2010 |
| CTL Scientific Supply Corp. eBcarryon Blood Glucose Monitoring System |
| K091765 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/20/2010 |
| Progressive Health Supply and Source Corporation, Smartest Pronto Blood Glucose Monitoring System |
| K091815 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/20/2010 |
| Arkray USA Inc. Assure Platinum Blood Glucose Monitoring System |
| K092104 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/12/2010 |
| Fora Care Inc. TD-4251A No-Coding Blood Glucose Monitoring System |
| K092099 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/08/2010 |
| Fora Care Inc. TD-4252C No-Coding Blood Glucose Monitoring System |
| K092099 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/08/2010 |
| Fora Care Inc. TD-4253A No-Coding Blood Glucose Monitoring System |
| K092099 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/08/2010 |
| Fora Care Inc. TD-4254A No-Coding Blood Glucose Monitoring System |
| K092099 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
01/08/2010 |
| Acceava Mono Cassette (For whole blood) |
| K961024 |
Infectious Mononucleosis Antibodies (Mono) |
General Immunology |
01/04/2010 |
| Siemens, CLINITEK Status Connect System |
| K091216 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status Connect System |
| K091216 |
Microalbumin |
General Chemistry |
01/04/2010 |
| Siemens, CLINITEK Status Connect System |
| K091216 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status Connect System |
| K091216 |
Urine Qualitative Dipstick Blood |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status Connect System |
| K091216 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status Connect System |
| K091216 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status Connect System |
| K091216 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status Connect System |
| K091216 |
Urine Qualitative Dipstick Ph |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status Connect System |
| K091216 |
Urine Qualitative Dipstick Protein |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status Connect System |
| K091216 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status Connect System |
| K091216 |
Urine Qualitative Dipstick Creatinine |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status Connect System |
| K091216 |
hCG, Urine |
Endocrinology |
01/04/2010 |
| Siemens, CLINITEK Status+ Analyzer |
| K091216 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status+ Analyzer |
| K091216 |
Microalbumin |
General Chemistry |
01/04/2010 |
| Siemens, CLINITEK Status+ Analyzer |
| K091216 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status+ Analyzer |
| K091216 |
Urine Qualitative Dipstick Blood |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status+ Analyzer |
| K091216 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status+ Analyzer |
| K091216 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status+ Analyzer |
| K091216 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status+ Analyzer |
| K091216 |
Urine Qualitative Dipstick Ph |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status+ Analyzer |
| K091216 |
Urine Qualitative Dipstick Protein |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status+ Analyzer |
| K091216 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status+ Analyzer |
| K091216 |
Urine Qualitative Dipstick Creatinine |
Urinalysis |
01/04/2010 |
| Siemens, CLINITEK Status+ Analyzer |
| K091216 |
hCG, Urine |
Endocrinology |
01/04/2010 |
| Biotest Medical Corporation, SuperCheck1 Blood Glucose Monitoring System |
| K091815 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
12/10/2009 |
| American Screening Corporation One Screen Drug Test Cards |
| K091588 |
Amphetamines |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation One Screen Drug Test Cups |
| K091588 |
Amphetamines |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation One Screen Drug Test Cups |
| K091588 |
Barbiturates |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cards |
| K091588 |
Cannabinoids (THC) |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cards |
| K091588 |
Phencyclidine (PCP) |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cards |
| K091588 |
Cocaine Metabolites |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cards |
| K091588 |
Opiates |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cards |
| K091588 |
Methadone |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cards |
| K091588 |
Methamphetamines |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cards |
| K091588 |
Benzodiazepines |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cards |
| K091588 |
Barbiturates |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cards |
| K091588 |
Morphine |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cards |
| K091588 |
Tricyclic Antidepressants |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cards |
| K091588 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cards |
| K091588 |
Oxycodone |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cups |
| K091588 |
Cannabinoids (THC) |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cups |
| K091588 |
Phencyclidine (PCP) |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cups |
| K091588 |
Cocaine Metabolites |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cups |
| K091588 |
Opiates |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cups |
| K091588 |
Methadone |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cups |
| K091588 |
Methamphetamines |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cups |
| K091588 |
Benzodiazepines |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cups |
| K091588 |
Morphine |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cups |
| K091588 |
Tricyclic Antidepressants |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cups |
| K091588 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
12/03/2009 |
| American Screening Corporation OneScreen Drug Test Cups |
| K091588 |
Oxycodone |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Amphetamines |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Cannabinoids (THC) |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Phencyclidine (PCP) |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Cocaine Metabolites |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Opiates |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Methadone |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Methamphetamines |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Benzodiazepines |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Barbiturates |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Morphine |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Tricyclic Antidepressants |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Methylenedioxymethamphetamine (MDMA) |
Toxicology / TDM |
12/03/2009 |
| Express Diagnostics International Inc. DrugCheck Waive Drug Test Cards |
| K091588 |
Oxycodone |
Toxicology / TDM |
12/03/2009 |
| Fora Care Inc. FORA D20/TD-3263 Blood Glucose Plus Blood Pressure Monitoring System |
| K091814 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
12/02/2009 |
| Infopia USA LipidPro lipid profile and glucose measuring system |
| K090405 |
Triglyceride |
General Chemistry |
12/02/2009 |
| Infopia USA LipidPro lipid profile and glucose measuring system |
| K090405 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
12/02/2009 |
| Infopia USA LipidPro lipid profile and glucose measuring system |
| K090405 |
HDL Cholesterol |
General Chemistry |
12/02/2009 |
| Infopia USA LipidPro lipid profile and glucose measuring system |
| K090405 |
Cholesterol |
General Chemistry |
12/02/2009 |
| Infopia USA LipidPro lipid profile and glucose measuring system {LipidPro Lipid Profile test strips} |
| K090405 |
Triglyceride |
General Chemistry |
12/02/2009 |
| Infopia USA LipidPro lipid profile and glucose measuring system {LipidPro Lipid Profile test strips} |
| K090405 |
HDL Cholesterol |
General Chemistry |
12/02/2009 |
| Infopia USA LipidPro lipid profile and glucose measuring system {LipidPro Lipid Profile test strips} |
| K090405 |
Cholesterol |
General Chemistry |
12/02/2009 |
| Cambridge Sensors ltd. microdot xtra Blood Glucose Monitoring System |
| K083273 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/23/2009 |
| Conception Technologies hCG One Step Pregnancy Test Device (urine/serum) |
| K993065 |
Urine hCG By Visual Color Comparison Tests |
Endocrinology |
11/17/2009 |
| Infopia USA GLUCOLAB Auto-coding Blood Glucose Monitoring System |
| K091157 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/17/2009 |
| Cardinal Health Leader Blood Glucose Monitoring System |
| K073573 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
11/13/2009 |
| CLIAwaived, Inc. Rapid Fecal Occult Blood Test |
| K061065 |
Fecal Occult Blood |
General Chemistry |
11/09/2009 |
| Princeton BioMeditech BioSign H. pylori WB {OSOM H. pylori} ((for whole blood) |
| K980798 |
Helicobacter Pylori Antibodies |
General Immunology |
11/09/2009 |
| Arkray ReliOn Confirm Blood Glucose Monitoring System |
| K073416 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/30/2009 |
| Arkray, GLUCOCARD VITAL Blood Glucose Monitoring System |
| K091102 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/30/2009 |
| Nova Biomedical Corp. StatStrip Xpress Glucose Hosptial Meter |
| K070960 |
Glucose Monitoring Devices (Prescription Use Only) |
General Chemistry |
10/30/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Blood |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Ph |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Protein |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
10/28/2009 |
| Acon Mission U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Blood |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Ph |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Protein |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
10/28/2009 |
| Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Ketone |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Bilirubin |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Blood |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Glucose |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Leukocytes |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Nitrite |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Ph |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Protein |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Urobilinogen |
Urinalysis |
10/28/2009 |
| RefuAH U120 Urine Analyzer |
| K070929 |
Urine Qualitative Dipstick Specific Gravity |
Urinalysis |
10/28/2009 |
| Genzyme Diagnostics OSOM ImmunoDip Urinary Albumin Test |
| K022538 |
Albumin, Urinary |
General Chemistry |
10/26/2009 |
| Fifty 50 Medical, Fifty 50 Glucose Monitoring System 2.0 |
| K083468 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/14/2009 |
| Major Biosystem Corp. AP-1000 Blood Glucose Monitoring System |
| K090389 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
10/14/2009 |
| Fora Care Inc. FORA G90 Blood Glucose Monitoring System |
| K091898 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/30/2009 |
| Fora Care Inc. U-Right TD-4234 Blood Glucose Monitoring System |
| K091898 |
Glucose Monitoring Devices (FDA Cleared/Home Use) |
General Chemistry |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Amphetamines |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Cannabinoids (THC) |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Phencyclidine (PCP) |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Cocaine Metabolites |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Opiates |
Toxicology / TDM |
09/30/2009 |
| UCP Biosciences, Inc. UCP Home Drug Screening Test Cards |
| K091588 |
Methadone |
Toxicol |