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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name epstein-barr virus, other
510(k) Number K062213
Device Name BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Applicant
BIO-RAD LABORATORIES, INC.
6565 185TH AVE., N.E.
REDMOND,  WA  98052
Applicant Contact DAVID BHEND
Correspondent
BIO-RAD LABORATORIES, INC.
6565 185TH AVE., N.E.
REDMOND,  WA  98052
Correspondent Contact DAVID BHEND
Regulation Number866.3235
Classification Product Code
LSE  
Subsequent Product Code
KTN  
Date Received08/01/2006
Decision Date 12/08/2006
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
Recalls CDRH Recalls
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