CLIA - Clinical Laboratory Improvement Amendments

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Analyte HDL Cholesterol Complexity waived

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Document	Analyte	Analyte Specialty	Effective Date
Polymer Technology Systems Cardiochek Brand Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips}
K071507	HDL Cholesterol	General Chemistry	09/21/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS CHOL+HDL+GLUC Panel Test Strips}
K071507	HDL Cholesterol	General Chemistry	09/21/2007
Cholestech LDX {Lipid Profile - ALT (GPT)} (Whole Blood)
K922612	HDL Cholesterol	General Chemistry	05/16/2007
Polymer Technology Systems CardioChek Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}
K070017	HDL Cholesterol	General Chemistry	02/07/2007
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS Metabolic Chemistry Panel Test Strips}
K070017	HDL Cholesterol	General Chemistry	02/07/2007
Abaxis, Piccolo xpress Chemistry Analyzer
K023640	HDL Cholesterol	General Chemistry	01/22/2007
Arkray SPOTCHEM EZ Chemistry Analyzer {Lipid Panel} (Whole Blood)
K042443	HDL Cholesterol	General Chemistry	12/12/2006
Polymer Technology Systems CardioChek Analyzer {PTS PANELS HDL Cholesterol Test Strips}
K060617	HDL Cholesterol	General Chemistry	04/10/2006
Polymer Technology Systems CardioChek PA Analyzer {PTS PANELS HDL Cholesterol Test Strips}
K060617	HDL Cholesterol	General Chemistry	04/10/2006
Polymer Technology Systems CardioChek Analyzer {PTS PANELS CHOL+HDL Test Panel Test Strips}
K023558	HDL Cholesterol	General Chemistry	09/27/2005