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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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11 to 20 of 88 Results
Analyte Cholesterol Complexity waived Effective Date To 04/16/2014
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Document Parent Analyte Analyte Specialty Effective Date
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System  
K090405   HDL cholesterol General Chemistry 01/04/2012
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System  
K090405   Cholesterol General Chemistry 01/04/2012
Alere Cholestech LDX  (Whole Blood)
K922612   HDL cholesterol General Chemistry 08/16/2011
Alere Cholestech LDX  (Whole Blood)
K922612   Cholesterol General Chemistry 08/16/2011
Infopia USA LipidPro lipid profile and glucose measuring system  
K090405   HDL cholesterol General Chemistry 12/02/2009
Infopia USA LipidPro lipid profile and glucose measuring system  
K090405   Cholesterol General Chemistry 12/02/2009
Infopia USA LipidPro lipid profile and glucose measuring system  {LipidPro Lipid Profile test strips} 
K090405   HDL cholesterol General Chemistry 12/02/2009
Infopia USA LipidPro lipid profile and glucose measuring system  {LipidPro Lipid Profile test strips} 
K090405   Cholesterol General Chemistry 12/02/2009
Roche Diagnostics Accutrend Plus System  (Fingerstick Whole Blood)
K051376   Cholesterol General Chemistry 01/29/2009
Wako APOLOWAKO Analyzer  (Whole Blood)
K080125   Cholesterol General Chemistry 10/31/2008

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