510(k) K180427 ยท DJG Enzyme Immunoassay, Opiates
ARK Fentanyl Assay
| Applicant | Ark Diagnostics, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Jun 6, 2018 |
| Received | Feb 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180427
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.