510(k) K153192 ยท DJG Enzyme Immunoassay, Opiates
Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
| Applicant | Chemtron Biotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 18, 2016 |
| Received | Nov 3, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153192
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.