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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameCIRRUS DIAGNOSTICS IMMULITE  
Document NumberK003372
Analyte NameC-reactive protein (CRP)
Analyte SpecialtyGeneral Immunology
ComplexityMODERATE
Effective Date12/29/2000
Device Classification Name system, test, c-reactive protein
510(k) Number K003372
Device Name IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP
Original Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 west 96th st.
los angeles,  CA  90045 -5597
Original Contact edwards m levine
Regulation Number866.5270
Classification Product Code
DCN  
Date Received10/30/2000
Decision Date 12/26/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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