CLIA - Tests waived by FDA from January 2000 to present

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

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Show All Test Systems Download Files | More About CLIA
Document	Test System Name Analyte	Analyte Specialty	Effective Date
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