510(k) K252684 ยท DJG Enzyme Immunoassay, Opiates
Labcorp Fentanyl Urine Visual Test
| Applicant | Medtox Diagnostics, Inc., Burlington NC, US |
| Decision | Substantially Equivalent, Jan 29, 2026 |
| Received | Aug 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252684
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.