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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
510(k) Number K043341
Device Name BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Applicant
BIO-RAD LABORATORIES, INC.
6565 185TH AVE., N.E.
REDMOND,  WA  98052
Applicant Contact CHRISTOPHER BENTSEN
Correspondent
BIO-RAD LABORATORIES, INC.
6565 185TH AVE., N.E.
REDMOND,  WA  98052
Correspondent Contact CHRISTOPHER BENTSEN
Regulation Number862.3100
Classification Product Code
NVI  
Date Received12/03/2004
Decision Date 10/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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