510(k) K913429 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS
| Applicant | Syva Co., Palo Alto CA, US |
| Decision | Substantially Equivalent, Aug 26, 1991 |
| Received | Aug 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913429
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.