510(k) K182123 ยท DJG Enzyme Immunoassay, Opiates
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
| Applicant | Advin Biotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 29, 2019 |
| Received | Aug 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182123
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.