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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibody Igm, If, Epstein-Barr Virus
510(k) Number K123021
Device Name BIOPLEX 2200 EBV IGM KIT
Applicant
Bio-Rad Laboratories
5500 Second St.
Benicia,  CA  94510
Applicant Contact Juang Wang
Correspondent
Bio-Rad Laboratories
5500 Second St.
Benicia,  CA  94510
Correspondent Contact Juang Wang
Regulation Number866.3235
Classification Product Code
LJN  
Subsequent Product Codes
JIX   JJY   KTN  
Date Received09/27/2012
Decision Date 11/02/2012
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
Predetermined Change
Control Plan Authorized		 No
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