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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameRoche Diagnostics Hitachi 911  
Document NumberK003400
Analyte NameC-reactive protein (CRP)
Analyte SpecialtyGeneral Immunology
ComplexityMODERATE
Effective Date05/18/2001
Device Classification Name system, test, c-reactive protein
510(k) Number K003400
Device Name CRP HS TEST SYSTEM
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
p.o. box 50416
indianapolis,  IN  46250 -0457
Original Contact kay a taylor
Regulation Number866.5270
Classification Product Code
DCN  
Date Received11/01/2000
Decision Date 05/10/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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