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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 - 509
Applicant Contact KENNETH T EDDS
Correspondent
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591 - 509
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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