510(k) K252523 · NFW Test, Cannabinoid, Over The Counter
Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test
| Applicant | Healgen Scientific,, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Feb 12, 2026 |
| Received | Aug 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252523
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.