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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 K063866
Device Name BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Applicant
Bio-Rad Laboratories
6565 185th Ave., NE
Redmond,  WA  98052
Applicant Contact DAVID BHEND
Correspondent
Bio-Rad Laboratories
6565 185th Ave., NE
Redmond,  WA  98052
Correspondent Contact DAVID BHEND
Regulation Number866.3830
Classification Product Code
LIP  
Date Received12/29/2006
Decision Date 03/19/2007
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
Recalls CDRH Recalls
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