510(k) K200197 ยท DJG Enzyme Immunoassay, Opiates
ARK Fentanyl II Assay
| Applicant | Ark Diagnostics, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Feb 26, 2020 |
| Received | Jan 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200197
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.