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CLIA - Tests waived by FDA from January 2000 to present

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Tests can be categorized as "waived" from regulatory oversite if they meet certain requirements established by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) law. By selecting a Test System Name, you can view the CLIA data for that Test System, including the corresponding 510(K) record, if applicable. The information is sorted first by the date of Categorization of the Test, then by Test System Name. This list does not include Test Systems that were characterized by the CDC prior to January 2000.
 
 
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Show All Test Systems Download Files | More About CLIA
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Fifty 50 Medical, Fifty 50 Glucose Monitoring System 2.0  
K083468 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
Fora Care Inc. U-Right TD-4250 Blood Glucose Monitoring System  
K083570 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/14/2009
Fora Care Inc. U-Right TD-4249 Blood Glucose Monitoring System  
K083570 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/14/2009
Fora Care Inc. U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System  
K090188 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/16/2009
Fora Care Inc., FORA V12 Blood Glucose Monitoring System  
K090404 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/16/2009
Fora Care, Inc., FORA V10 Blood Glucose Monitoring System  
K090404 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/16/2009
Fora Care FORA V22 Blood Glucose Monitoring System  
K081609 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/12/2009
Fora Care Inc. U-Right TD-4225 Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/12/2009
Fora Care Inc. FORA V10 Blood Glucose Monitoring System  
K081715 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2009
Fora Care Inc. FORA G30 Blood Glucose Monitoring System  
K090187 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/29/2009
Fora Care Inc. FORA V12 No-Coding Blood Glucose Monitoring System  
K090536 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/16/2009
Fora Care Inc. FORA TD-4251 Blood Glucose Monitoring System  
K082482 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/03/2009
Fora Care Inc. U-Right TD-4252A Blood Glucose Monitoring System  
K082482 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/03/2009
Fora Care Inc. U-Right TD-4252B Blood Glucose Monitoring System  
K082482 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/03/2009
Fora Care Inc. U-Right TD-4254 Blood Glucose Monitoring System  
K082482 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/03/2009
Fora Care Inc. FORA TD-4245 Blood Glucose Monitoring System  
K083664 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/12/2009
Fora Care Inc. FORA D15c Blood Glucose Plus Pressure Monitoring System  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/05/2009
Fora Care Inc. FORA TD-4244 Blood Glucose Monitoring System  
K081715 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/05/2009
Fora Care Inc. FORA D15b Blood Glucose Plus Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2008
Fora Care Inc. FORA D15z Blood Glucose Plus Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2008
Fora Care Inc. FORA D-10 Blood Glucose plus Blood Pressure Monitoring System  
K081714 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/13/2008
Fora Comfort 2 in 1 TD-3250C Blood Glucose and Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Fora Comfort 2 in 1 TD-3260 Blood Glucose Plus Blood Pressure Monitoring System  
K080014 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2008
Fora Care AudioChek Talking Mointors Blood Glucose Monitoring System Model TD-4237  
K081609 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008
Fora Care Clever Chek TD-4237 Blood Glucose Monitoring System  
K081609 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008
Fora Care Inc. FORA TD-3224 Blood Glucose Plus Blood Pressure Monitoring System  
K081714 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/30/2008
Fora Care Inc. Fora Comfort 2 in 1 Blood Glucose Plus Blood Pressure Monitoring System TD-3250  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/26/2008
Fertell Male Fertility Test   
K041039 Semen Hematology 06/18/2007
Fisher Healthcare Sure-Vue H. pylori Test  (Whole Blood)
K024350 Helicobacter Pylori Antibodies General Immunology 06/11/2007
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test  
K063693 Fecal Occult Blood General Chemistry 05/16/2007
Fisher HealthCare Sure-Vue Serum/Urine hCG-STAT  
K062361 hCG, Urine Endocrinology 04/02/2007
Fisher HealthCare Sure-Vue Urine hCG  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 03/29/2007
Fisher HealthCare Sure-Vue Serum/Urine hCG  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 03/28/2007
Fisher HealthCare Sure-Vue Strep A Test  
K010582 Streptococcus, Group A Bacteriology 03/28/2007
Fisher HealthCare Sure-Vue Urine hCG Strip  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 03/07/2007
First Check Diagnostics LLC, First Check Home Drug Test Marijuana  
K050936 Cannabinoids (THC) Toxicology / TDM 05/01/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Amphetamines Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Cannabinoids (THC) Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Phencyclidine (PCP) Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Cocaine Metabolites Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Opiates Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Methadone Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Methamphetamines Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Benzodiazepines Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Barbiturates Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Tricyclic Antidepressants Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/22/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Oxycodone Toxicology / TDM 02/22/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Amphetamines Toxicology / TDM 01/17/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Cannabinoids (THC) Toxicology / TDM 01/17/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Phencyclidine (PCP) Toxicology / TDM 01/17/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Cocaine Metabolites Toxicology / TDM 01/17/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Opiates Toxicology / TDM 01/17/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Methamphetamines Toxicology / TDM 01/17/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/17/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Amphetamines Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Cannabinoids (THC) Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Phencyclidine (PCP) Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Cocaine Metabolites Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Opiates Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Methadone Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Methamphetamines Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Benzodiazepines Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Barbiturates Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Tricyclic Antidepressants Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/10/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Oxycodone Toxicology / TDM 01/10/2006
Fisher Scientific Sure-Vue RSV Test  
K022845 Respiratory Syncytial Virus Virology 10/20/2005
Family Pharmacy TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
FOREFRONT DIAGNOSTICS INSTACHECK DRUG SCREEN THC  
K971959 Cannabinoids (THC) Toxicology / TDM 01/23/2003
FOREFRONT DIAGNOSTICS INSTACHECK MULTI-DRUG SCREEN PANEL  (THC/COC)
K993863 Cannabinoids (THC) Toxicology / TDM 01/23/2003
FOREFRONT DIAGNOSTICS INSTACHECK MULTI-DRUG SCREEN PANEL  (THC/COC)
K993863 Cocaine Metabolites Toxicology / TDM 01/23/2003
FEMTEK PHEM-ALERT  
K012230 Vaginal pH General Chemistry 10/09/2001
FISHER HEALTHCARE SURE-VUE FECAL OCCULT BLOOD  
K911075 Fecal Occult Blood General Chemistry 09/27/2001
FOREFRONT DIAGNOSTICS DRUGFREE@HOME THC/COC TEST KIT  
K002253 Cannabinoids (THC) Toxicology / TDM 07/10/2001
FOREFRONT DIAGNOSTICS DRUGFREE@HOME THC/COC TEST KIT  
K002253 Cocaine Metabolites Toxicology / TDM 07/10/2001
FACT PLUS PRO PREGNANCY TEST  
K990576 Urine hCG By Visual Color Comparison Tests Endocrinology 12/13/2000
FACT PLUS SELECT PREGNANCY TEST  
K965184 Urine hCG By Visual Color Comparison Tests Endocrinology 12/13/2000
 
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