510(k) K790255 ยท KLT Enzyme Immunoassay, Carbamazepine
EMIT AED ASSAYS 3500 COMPUTER DIRECTED
| Applicant | Syva Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 2, 1979 |
| Received | Feb 6, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K790255
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.