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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameDU PONT ANALYST  {HEMAGEN ANALYSTICAL TEST ROTOR} 
Document NumberK010864
Analyte NameGlucose
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date03/14/2002
Device Classification Name enzymatic, carbon-dioxide
510(k) Number K010864
Device Name ANALYST PANELS + ANALYTICAL TEST ROTOR
Original Applicant
HEMAGEN DIAGNOSTICS, INC.
9033 red branch rd.
columbia,  MD  21045
Original Contact jose a montanez
Regulation Number862.1160
Classification Product Code
KHS  
Subsequent Product Codes
CEO   CIG   CIX  
Date Received03/22/2001
Decision Date 05/21/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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