FDA 510(k) Applications for Medical Device Product Code "NCW"
(System, Test, Her-2/Neu, Monitoring)

FDA 510(k) Number Applicant Device Name Decision Date
K024017 BAYER CORP. BAYER ADVIA CENTAUR HER-2/NEU ASSAY 01/30/2003
K992228 BAYER CORP. BAYER IMMUNO 1 HER-2/NEU ASSAY 09/29/2000
K994112 ONCOGENE SCIENCE, INC. MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) 09/29/2000


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