510(k) K182779 ยท DJR Enzyme Immunoassay, Methadone
ARK EDDP Assay
| Applicant | Ark Diagnostics, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Nov 21, 2018 |
| Received | Oct 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182779
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.