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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
5500 east 2nd st.
benicia,  CA  94510
Original Contact juang wang
Regulation Number866.3510
Classification Product Code
Subsequent Product Codes
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