510(k) K992890 ยท DJG Enzyme Immunoassay, Opiates
ROCHE COBAS INTEGRA OPIATES 300/2000
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 23, 1999 |
| Received | Aug 27, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992890
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.