510(k) K946199 ยท CHP Radioimmunoassay, Estradiol
AURAFLEX(R) ESTRADIOL
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Apr 3, 1995 |
| Received | Dec 20, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946199
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.