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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Glucose Complexity waived
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Document Analyte Analyte Specialty Effective Date
Wako APOLOWAKO Analyzer  {Whole Blood} 
K080123 Glucose General Chemistry 10/31/2008
Abaxis, Piccolo xpress Chemistry Analyzer  {Lipid Panel Plus Reagent Disc} (Whole Blood)
K942782 Glucose General Chemistry 04/14/2008
Abaxis Piccolo Blood Chemistry Analyzer  {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Glucose General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer  {Basic Metabolic Reagent Disc} (Whole Blood)
K993211 Glucose General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer  {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Glucose General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer  {Basic Metabolic Reagent Disc} (Whole Blood)
K993211 Glucose General Chemistry 10/30/2007
Abbott i-STAT CHEM8+ Catridge  (Venous Whole blood)
K053110 Glucose General Chemistry 09/21/2007
Polymer Technology Systems Cardiochek Brand Analyzer  {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} 
K071507 Glucose General Chemistry 09/21/2007
Polymer Technology Systems CardioChek PA Analyzer  {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} 
K071507 Glucose General Chemistry 09/21/2007
Arkray SPOTCHEM EZ Chemistry Analyzer  {Spotchem II Basicpanel 1} (Whole Blood)
K053401 Glucose General Chemistry 05/31/2007

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