510(k) K983190 ยท DJG Enzyme Immunoassay, Opiates
DBEST OPIATES TEST KIT
| Applicant | Ameritek, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Nov 18, 1998 |
| Received | Sep 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983190
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.