510(k) K913066 ยท KLT Enzyme Immunoassay, Carbamazepine
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
| Applicant | Syva Co., Palo Alto CA, US |
| Decision | Substantially Equivalent, Jul 30, 1991 |
| Received | Jul 10, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913066
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.