510(k) K992228 ยท NCW System, Test, Her-2/Neu, Monitoring
BAYER IMMUNO 1 HER-2/NEU ASSAY
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Sep 29, 2000 |
| Received | Jul 2, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992228
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.