510(k) K943712 ยท DJG Enzyme Immunoassay, Opiates
VERDICT OPIATES
| Applicant | Editek, Inc., Burlington NC, US |
| Decision | Substantially Equivalent, Nov 17, 1994 |
| Received | Aug 1, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943712
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.