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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
YOUR 1ST CHOICE FOR VALUE! TRUETRACK SMART SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
YD DIAGNOSTICS PREG-Q PREGNANCY TEST  
K023027 Urine hCG By Visual Color Comparison Tests Endocrinology 12/17/2002
 
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