510(k) K855026 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
ACCULEVEL PHENYTOIN TEST
| Applicant | Syva / A Syntex Co., Palo Alto CA, US |
| Decision | Substantially Equivalent, Aug 25, 1986 |
| Received | Dec 16, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K855026
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.