510(k) K811025 ยท LES Fluorescent Immunoassay, Diphenylhydantoin
AMES TDA TM PHENYTOIN TEST
| Applicant | Miles Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 29, 1981 |
| Received | Apr 16, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811025
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.