510(k) K192433 ยท DJR Enzyme Immunoassay, Methadone
LZI Methadone II Enzyme Immunoassay
| Applicant | Lin-Zhi International, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Oct 4, 2019 |
| Received | Sep 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192433
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.