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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