CLIA - Clinical Laboratory Improvement Amendments

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Analyte HDL Cholesterol Complexity waived

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Document	Analyte	Analyte Specialty	Effective Date
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System
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
Infopia USA LipidPro lipid profile and glucose measuring system {LipidPro Lipid Profile test strips}
K090405	HDL Cholesterol	General Chemistry	12/02/2009
Abaxis Piccolo Blood Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023640	HDL Cholesterol	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023640	HDL Cholesterol	General Chemistry	04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023640	HDL Cholesterol	General Chemistry	04/14/2008
Accutech CholesTrak HDL Cholesterol Home Test
K072836	HDL Cholesterol	General Chemistry	01/08/2008
Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL Panel Test Strips}
K071593	HDL Cholesterol	General Chemistry	10/15/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL Panel Test Strips}
K071593	HDL Cholesterol	General Chemistry	10/15/2007