510(k) K820187 ยท LES Fluorescent Immunoassay, Diphenylhydantoin
SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY
| Applicant | Syva Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 12, 1982 |
| Received | Jan 25, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820187
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.