510(k) K031032 ยท DJG Enzyme Immunoassay, Opiates
VERDICT II, PROFILE II
| Applicant | Medtox Diagnostics, Inc., Burlington NC, US |
| Decision | Substantially Equivalent, Jul 14, 2003 |
| Received | Apr 1, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031032
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.