510(k) K955562 ยท LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
INNOFLUOR PHENYTOIN ASSAY SYSTEM
| Applicant | Oxis Intl., Inc., Portland OR, US |
| Decision | Substantially Equivalent, Jan 24, 1996 |
| Received | Dec 6, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955562
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.