510(k) K864607 ยท LBZ Enzyme Immunoassay, Quinidine
EASY-TEST QUINIDINE ITEM NO. 67---/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jan 8, 1987 |
| Received | Nov 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864607
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.