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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name antibodies, anti-cyclic citrullinated peptide (ccp)
510(k) Number K112810
Device Name MULTI-ANALYTE DETECTION SYSTEMS
Original Applicant
BIO-RAD LABORATORIES
bioplex 2200 division
5500 east second st
benicia,  CA  94510
Original Contact juang wang
Regulation Number866.5775
Classification Product Code
NHX  
Date Received09/27/2011
Decision Date 10/26/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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