510(k) K862349 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jul 7, 1986 |
| Received | Jun 20, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862349
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.