510(k) K843824 ยท LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR
| Applicant | Roche Diagnostic Systems, Inc., Nutley NJ, US |
| Decision | Substantially Equivalent, Feb 1, 1985 |
| Received | Sep 28, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843824
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.