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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
Kurkel Enterprises Early-Pregnancy-Tests.com Ovulation Midstream Tests  
X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 06/25/2007
Kurkel Enterprises Early-Pregnancy-Tests.com Ovulation Test Strips  
X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 06/25/2007
KoreaMedico Chextic  
K062096 Urine hCG By Visual Color Comparison Tests Endocrinology 05/10/2007
Kurkel Enterprises Early-Pregnancy-Tests.com Pregnancy Midstream Tests  
K974059 Urine hCG By Visual Color Comparison Tests Endocrinology 03/19/2007
Kurkel Enterprises Early-Pregnancy-Tests.com Pregnancy Test Strips  
K951705 Urine hCG By Visual Color Comparison Tests Endocrinology 03/19/2007
Kareway Product Pure-Aid Pregnancy Test  
K053452 Urine hCG By Visual Color Comparison Tests Endocrinology 05/31/2006
Kmart Corp. American Fare TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
Kroger Blood Glucose Monitoring System  
K983504 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/10/2002
KDK CORPORATION LACTATE PRO SYSTEM  (For OTC use)
K980908 Lactic Acid (Lactate) General Chemistry 07/27/2001
KINRAY PREFERRED PLUS BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/19/2000
KERR BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
 
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