510(k) K895827 ยท LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET
| Applicant | Innotron of Oregon, Inc., Portland OR, US |
| Decision | Substantially Equivalent, Oct 31, 1989 |
| Received | Oct 2, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895827
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.