510(k) K871306 ยท KLT Enzyme Immunoassay, Carbamazepine
EMIT CARBAMAZEPINE ASSAY
| Applicant | Syva Co., Palo Alto CA, US |
| Decision | Substantially Equivalent, Apr 14, 1987 |
| Received | Apr 1, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871306
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.