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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
Nova Biomedical Corp. StatStrip Xpress Glucose Hosptial Meter  
K070960 Glucose Monitoring Devices (Prescription Use Only) General Chemistry 10/30/2009
National Distribution and Contracting Inc., Pro Advantage by NDC Urine/Serum Pregnancy Cassette Device  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 07/01/2009
National Distribution and Contracting Inc., Pro Advantage by NDC Urine Pregnancy Cassette Device  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 06/08/2009
National Diagnostic Products Betachek Blood Glucose (Sugar) Test  
K062187 Whole Blood Qualitative Dipstick Glucose General Chemistry 04/22/2009
Nova Biomedical Nova Gold Blood Glucose Monitoring System  
K070255 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/13/2008
Neuero Engineering Inc. 3test Supreme Glucose Monitoring System  
K072905 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/18/2008
Nova Biomedical Corp. StatStrip Glucose Hospital Meter  
K060345 Glucose Monitoring Devices (Prescription Use Only) General Chemistry 02/28/2008
Nova Biomedical, Nova Max Link Blood Glucose Monitoring System  
K040603 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/28/2008
Nova Biomedical Nova Max Blood Glucose Monitoring System  
K070255 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/18/2007
Natureplex, LLC BE CERTAIN Home Pregnancy Test  
K051963 Urine hCG By Visual Color Comparison Tests Endocrinology 01/12/2007
Noble Medical Inc. Split-Specimen Cup  
K050878 Amphetamines Toxicology / TDM 04/19/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Cannabinoids (THC) Toxicology / TDM 04/19/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Phencyclidine (PCP) Toxicology / TDM 04/19/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Cocaine Metabolites Toxicology / TDM 04/19/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Opiates Toxicology / TDM 04/19/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Methamphetamines Toxicology / TDM 04/19/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 04/19/2006
NEO DIAGNOSTICS INC. KETOCHECKS  
K033114 Urine Qualitative Dipstick Ketone Urinalysis 02/15/2005
NEWTEK RELION BLOOD GLUCOSE MONITORING SYSTEM  
K024347 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/29/2003
 
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