510(k) K170416 ยท DJR Enzyme Immunoassay, Methadone
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
| Applicant | Lin-Zhi International, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jun 26, 2017 |
| Received | Feb 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170416
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.