510(k) K013482 ยท DJG Enzyme Immunoassay, Opiates
ABUSCREEN ONLINE OPIATES 300 / 2000
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 21, 2001 |
| Received | Oct 19, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013482
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.