510(k) K897114 ยท KLT Enzyme Immunoassay, Carbamazepine
EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
| Applicant | Syva Co., Palo Alto CA, US |
| Decision | Substantially Equivalent, Jan 18, 1990 |
| Received | Dec 26, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897114
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.