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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 K041658
Device Name BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
Applicant
Bio-Rad Laboratories, Inc.
6565 185th Ave., NE
Redmond,  WA  98052
Applicant Contact CHRISTOPHER BENSTEN
Correspondent
Bio-Rad Laboratories, Inc.
6565 185th Ave., NE
Redmond,  WA  98052
Correspondent Contact CHRISTOPHER BENSTEN
Regulation Number866.5100
Classification Product Code
LKJ  
Subsequent Product Codes
LJM   LKO   LLL   LRM   MQA  
Date Received06/18/2004
Decision Date 12/20/2004
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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