510(k) K251634 ยท DJG Enzyme Immunoassay, Opiates
LZI Fentanyl III Enzyme Immunoassay
| Applicant | Lin-Zhi International, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jun 18, 2025 |
| Received | May 29, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K251634
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.