510(k) K864554 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
EASY-TEST PRIMIDONE ITEM NO. 67---/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jan 7, 1987 |
| Received | Nov 19, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864554
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.