510(k) K240949 · NGL Test, Opiates, Over The Counter
Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid
| Applicant | Healgen Scientific,, LLC, Houston TX, US |
| Decision | Substantially Equivalent, May 13, 2024 |
| Received | Apr 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240949
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.