510(k) K952555 ยท MOJ Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jul 31, 1995 |
| Received | Jun 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952555
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.