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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  {WAKO CRP-UL} 
Document NumberK003342
Analyte NameC-reactive protein (CRP)
Analyte SpecialtyGeneral Immunology
ComplexityMODERATE
Effective Date01/23/2001
Device Classification Name system, test, c-reactive protein
510(k) Number K003342
Device Name WAKO CRP-UL, CRP-UL CALIBRATOR SET
Original Applicant
WAKO CHEMICALS, USA, INC.
1600 bellwood road
richmond,  VA  23237
Original Contact tonya malloy
Regulation Number866.5270
Classification Product Code
DCN  
Subsequent Product Code
JIS  
Date Received10/25/2000
Decision Date 01/22/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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