510(k) K181159 ยท DJG Enzyme Immunoassay, Opiates
LZI Fentanyl Enzyme Immunoassay
| Applicant | Lin-Zhi International, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Dec 3, 2018 |
| Received | May 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181159
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.