510(k) K880294 ยท LFO Nephelometric Inhibition Immunoassay, Diphenylhydantoin
DART PHENYTOIN
| Applicant | Coulter Electronics, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, May 27, 1988 |
| Received | Jan 25, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880294
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.