510(k) K093867 ยท DJG Enzyme Immunoassay, Opiates
ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 11, 2011 |
| Received | Jan 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093867
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.