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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 immunosorbent assay, herpes simplex virus, hsv-1
510(K) Number K120959
Device Name BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
Applicant
BIO-RAD LABORATORIES
bioplex 2200 division
5500 east second st
benicia,  CA  94510
Contact juang wang
Regulation Number866.3305
Classification Product Code
MXJ  
Subsequent Product Codes
JIX   JJY   MYF  
Date Received03/30/2012
Decision Date 06/22/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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