510(k) K252520 · DJG Enzyme Immunoassay, Opiates
SEFRIA Hydrocodone Oral Fluid
| Applicant | Immunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, Sep 11, 2025 |
| Received | Aug 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252520
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.