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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameDade Behring Dimension  {DADE BEHRING HIGH SENSITIVITY C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE} 
Document NumberK003419
Analyte NameC-reactive protein (CRP)
Analyte SpecialtyGeneral Immunology
ComplexityMODERATE
Effective Date02/05/2001
Device Classification Name system, test, c-reactive protein
510(k) Number K003419
Device Name RCRP FLEX REAGENT CARTRIDGE
Original Applicant
DADE BEHRING, INC.
glasgow business community;
bldg. 500 mail box 514
p.o. box 6101, newark,  DE  19714 -6101
Original Contact lorraine h pietrak
Regulation Number866.5270
Classification Product Code
DCN  
Date Received11/02/2000
Decision Date 02/14/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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