510(k) K024017 ยท NCW System, Test, Her-2/Neu, Monitoring
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jan 30, 2003 |
| Received | Dec 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024017
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2020 | Siemens Healthcare Diagnostics, Inc Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes:
(01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130
Atellica IM HER-2/neu (H Terminated |
NCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.