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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Anticardiolipin Immunological
510(k) Number K130528
Device Name BIOPLEX 2200 APLS IGM
Applicant
Bio-Rad Laboratories
5500 E. 2nd St.
Benicia,  CA  94510
Applicant Contact Juang Wang
Correspondent
Bio-Rad Laboratories
5500 E. 2nd St.
Benicia,  CA  94510
Correspondent Contact Juang Wang
Regulation Number866.5660
Classification Product Code
MID  
Subsequent Product Codes
JIX   JJX   MSV  
Date Received03/01/2013
Decision Date 10/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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