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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Cholesterol Complexity waived Effective Date To 07/23/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer  (Capillary-fingerstick)
K130200   Cholesterol General Chemistry 03/21/2014
Abaxis Piccolo xpress Chemistry Analyzer  (Capillary-fingerstick)
K120662   HDL cholesterol General Chemistry 03/21/2014
Abaxis Piccolo xpress Chemistry Analyzer  (Capillary-fingerstick)
CW140001 K130200 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  
K130295   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
Jant Pharmacal Corp, LipidPlus Professional Lipid Profile and Glucose Measuring System  {LipidPlus Lipid Profile test strips} 
K130295   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  {LipidPro Lipid Profile test strips} 
K130295   Cholesterol General Chemistry 07/01/2013

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