510(k) K201938 ยท DJG Enzyme Immunoassay, Opiates
LZI Fentanyl II Enzyme Immunoassay
| Applicant | Lin-Zhi International, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Aug 7, 2020 |
| Received | Jul 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201938
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.