510(k) K253082 ยท DJG Enzyme Immunoassay, Opiates
LZI Buprenorphine II Enzyme Immunoassay
| Applicant | Lin-Zhi International, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jan 16, 2026 |
| Received | Sep 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253082
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.