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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
Applicant Contact Juang Wang
Correspondent
Bio-Rad Laboratories
BIOPLEX 2200 DIVISION
5500 EAST SECOND ST
BENICIA,  CA  94510
Correspondent 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 (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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