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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 K090409
Device Name BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Applicant
Bio-Rad Laboratories
6565 185th Ave., NE
Redmond,  WA  98052
Applicant Contact DAVID V BHEND
Correspondent
Bio-Rad Laboratories
6565 185th Ave., NE
Redmond,  WA  98052
Correspondent Contact DAVID V BHEND
Regulation Number866.3305
Classification Product Code
MXJ  
Subsequent Product Code
MYF  
Date Received02/18/2009
Decision Date 05/08/2009
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
Predetermined Change
Control Plan Authorized		 No
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