510(k) K813538 ยท LES Fluorescent Immunoassay, Diphenylhydantoin
PHENYTOIN FLUORESCENT IMMUNOASSAY
| Applicant | American Diagnostic Corp., Walker MI, US |
| Decision | Substantially Equivalent, Dec 31, 1981 |
| Received | Dec 21, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813538
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.