510(k) K251972 · DJG Enzyme Immunoassay, Opiates
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)
| Applicant | Healgen Scientific,, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Aug 15, 2025 |
| Received | Jun 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251972
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.