510(k) K994112 ยท NCW System, Test, Her-2/Neu, Monitoring
MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
| Applicant | Oncogene Science, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Sep 29, 2000 |
| Received | Dec 6, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994112
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.