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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
 
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Document Analyte Analyte Specialty Effective Date
Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System  
K090405 Cholesterol General Chemistry 01/04/2012
Alere Cholestech LDX  (Whole Blood)
K922612 Cholesterol General Chemistry 08/16/2011
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 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
Abaxis Piccolo Blood Chemistry Analyzer  {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023642 Cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer  {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023642 Cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer  {Lipid Panel Reagent Disc} (Whole Blood)
K023642 Cholesterol General Chemistry 04/14/2008
Polymer Technology Systems Cardiochek Brand Analyzer  {PTS PANELS CHOL+HDL Panel Test Strips} 
K071593 Cholesterol General Chemistry 10/15/2007

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