510(k) K963529 ยท DIS Enzyme Immunoassay, Barbiturate
VERDICT BARBITURATES
| Applicant | Editek, Inc., Burlington NC, US |
| Decision | Substantially Equivalent, Oct 30, 1996 |
| Received | Sep 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963529
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.