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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 K992228
Device Name BAYER IMMUNO 1 HER-2/NEU ASSAY
Applicant
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact GABRIEL J MURACA
Correspondent
Bayer Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact GABRIEL J MURACA
Regulation Number866.6010
Classification Product Code
NCW  
Date Received07/02/1999
Decision Date 09/29/2000
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
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