510(k) K253567 ยท NGL Test, Opiates, Over The Counter
Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
| Applicant | Healgen Scientific,, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Dec 23, 2025 |
| Received | Nov 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253567
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.