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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Antigen, Control
510(k) Number K113610
FOIA Releasable 510(k) K113610
Device Name ANA-SCREEN WITH MDSS
Applicant
Bio-Rad Laboratories
Bioplex 2200 Division
5500 E. Second St.
Benicia,  CA  94510
Applicant Contact Juang Wang
Correspondent
Bio-Rad Laboratories
Bioplex 2200 Division
5500 E. Second St.
Benicia,  CA  94510
Correspondent Contact Juang Wang
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received12/06/2011
Decision Date 07/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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