510(k) K936131 ยท LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Mar 11, 1994 |
| Received | Dec 23, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936131
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.