510(k) K781958 ยท KLT Enzyme Immunoassay, Carbamazepine
ANALYTICAL TEST PACK, CARBAMAZEPINE
| Applicant | E.I. Dupont DE Nemours & Co., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 10, 1979 |
| Received | Nov 21, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K781958
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.