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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
Vertex Diagnostics UltraTRAK PRO Blood Glucose Monitoring System  
K082618 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/17/2008
Vertex Diagnostics UltraTRAK Blood Glucose Monitoring System  
K062235 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/16/2007
Visgeneer, Inc. eBsensor Blood Glucose Monitoring System  
K062555 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/02/2007
VIP Diagnostics LLC EZ Smart Blood Glucose Monitoring System  
K043340 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2005
VIP International Wholesalers, Corp. Ez Smart Blood Glucose Monitoring System  
K040848 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/17/2005
VICTORCH HCG STRIP  
K013702 Urine hCG By Visual Color Comparison Tests Endocrinology 01/03/2002
VICTORCH HCG TEST CARD  
K013678 Urine hCG By Visual Color Comparison Tests Endocrinology 01/03/2002
VALU-RITE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/22/2001
 
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