510(k) K831154 ยท LES Fluorescent Immunoassay, Diphenylhydantoin
STRATUS PHENYTOIN FLUOROMETRIC ENZYME
| Applicant | American Dade, Walker MI, US |
| Decision | Substantially Equivalent, May 16, 1983 |
| Received | Apr 8, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831154
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.