510(k) K852318 ยท LFT Fluorescent Immunoassay, Primidone
COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS
| Applicant | Roche Diagnostic Systems, Inc., Nutley NJ, US |
| Decision | Substantially Equivalent, Jun 25, 1985 |
| Received | May 31, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852318
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.