510(k) K240351 ยท NGL Test, Opiates, Over The Counter
FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
| Applicant | Assure Tech., LLC, Wilmington DE, US |
| Decision | Substantially Equivalent, Mar 6, 2024 |
| Received | Feb 5, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240351
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.