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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
Fora Care Inc. TD-4257 Blood Glucose Monitoring System  
K112963 Glucose General Chemistry 01/11/2012
Fora Care Inc. TD-4257 Multi Blood Glucose Monitoring System  
K112963 Glucose General Chemistry 01/11/2012
Alere Cholestech LDX  (Whole Blood)
K932727 Glucose General Chemistry 08/16/2011
Abaxis Piccolo Blood Chemistry Analyzer  {Piccolo Renal Function Panel} (Whole Blood)
K942782 Glucose General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer  {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782 Glucose General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer  {Piccolo Metlyte 8 Panel Reagent Disc} (Whole Blood)
K942782 Glucose General Chemistry 12/04/2008
Abaxis Piccolo xpress Chemistry Analyzer  {Piccolo Renal Function Panel} (Whole Blood)
K942782 Glucose General Chemistry 12/04/2008
Abbott i-STAT 6+ Cartridge  (Venous Whole blood)
K053110 Glucose General Chemistry 11/13/2008
Abbott i-STAT EC4+ Cartridge  (Venous Whole blood)
K053110 Glucose General Chemistry 11/13/2008
Abbott i-STAT G Cartridge  (Venous Whole blood)
K053110 Glucose General Chemistry 11/13/2008

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