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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
Polymer Technology Systems CardioChek PA Analyzer  {PTS PANELS CHOL+GLU TEST PANEL} (Professional Use)
K041750 Glucose General Chemistry 02/15/2005
TOTAL DIAGNOSTIC SALES, INC. TEST TIME HOME GLUCOSE TEST  
K943503 Glucose General Chemistry 06/07/2004
HEMOCUE GLUCOSE 201 MICROCUVETTES AND GLUCOSE 201 ANALYZER WITH PLASMA CONVERSION  
K020935 Glucose General Chemistry 07/12/2002
CHOLESTECH L.D.X.  
K932727 Glucose General Chemistry 01/23/1996
HemoCue B-Glucose System  
  Glucose General Chemistry 04/27/1995

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