510(k) K172416 ยท DJG Enzyme Immunoassay, Opiates
Synermed Opiate Enzyme Immunoassay
| Applicant | Infrared Laboratory Systems, LLC (Dba Synermed), Westfield IN, US |
| Decision | Substantially Equivalent, Apr 19, 2018 |
| Received | Aug 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172416
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.