510(k) K850807 ยท KLT Enzyme Immunoassay, Carbamazepine
COBAS FP REAGENTS FOR CARBAMAZEPINE
| Applicant | Roche Diagnostic Systems, Inc., Belleville NJ, US |
| Decision | Substantially Equivalent, Mar 22, 1985 |
| Received | Feb 27, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850807
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.