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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzyme linked immunoabsorption assay, treponema pallidum
510(k) Number K120439
Model 2200
Device Name BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
Original Applicant
BIO-RAD LABORATORIES, INC.
5500 east 2nd st.
benicia,  CA  94510
Original Contact juang wang
Regulation Number866.3830
Classification Product Code
LIP  
Subsequent Product Codes
JIX   JJY   LSE  
Date Received02/13/2012
Decision Date 03/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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