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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name multiplex flow immunoassay, t.gondii, rubella and cmv.
510(k) Number K120572
Device Name BIOPLEX 2200 TORC IGG
Original Applicant
BIO-RAD LABORATORIES, INC.
5500 east 2nd st.
benicia,  CA  94510
Original Contact juang wang
Regulation Number866.3510
Classification Product Code
OMI  
Subsequent Product Codes
JIX   JJY  
Date Received02/27/2012
Decision Date 03/26/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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