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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
Device Name BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
Applicant
BIO-RAD LABORATORIES, INC.
5500 EAST 2ND ST.
BENICIA,  CA  94510
Applicant Contact Juang Wang
Correspondent
BIO-RAD LABORATORIES, INC.
5500 EAST 2ND ST.
BENICIA,  CA  94510
Correspondent 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 (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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