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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, her-2/neu, monitoring
510(k) Number K024017
Device Name BAYER ADVIA CENTAUR HER-2/NEU ASSAY
Applicant
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Applicant Contact KENNETH T EDDS
Correspondent
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Correspondent Contact KENNETH T EDDS
Regulation Number866.6010
Classification Product Code
NCW  
Date Received12/04/2002
Decision Date 01/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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