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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte HDL Cholesterol Complexity waived Effective Date To 11/26/2014
 
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Abaxis Piccolo xpress Chemistry Analyzer  (Capillary-fingerstick)
K120662   HDL cholesterol General Chemistry 03/21/2014
Abaxis Piccolo xpress Chemistry Analyzer  (Capillary-fingerstick)
CW130006 K120662 HDL cholesterol General Chemistry 03/21/2014
Jant Pharmacal Corp, LipidPlus Professional Lipid Profile and Glucose Measuring System  
K130295   HDL cholesterol General Chemistry 11/12/2013
Jant Pharmacal Corp, LipidPlus Professional Lipid Profile and Glucose Measuring System  {LipidPlus Lipid Profile test strips} 
K130295   HDL cholesterol General Chemistry 11/12/2013
INFOPIA USA, LipidPro┬« Professional Lipid Profile and Glucose Measuring System  {LipidPro Lipid Profile test strips} 
K130295   HDL cholesterol General Chemistry 07/01/2013
INFOPIA USA, LipidPro┬« Professional Lipid Profile and Glucose Measuring System  
K130295   HDL cholesterol General Chemistry 07/01/2013
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  {LipidPro Lipid Profile test strips} 
K090405   HDL cholesterol General Chemistry 01/04/2012
Alere Cholestech LDX  (Whole Blood)
K922612   HDL cholesterol General Chemistry 08/16/2011
Infopia USA LipidPro lipid profile and glucose measuring system  
K090405   HDL cholesterol General Chemistry 12/02/2009

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