510(k) K043211 ยท DIS Enzyme Immunoassay, Barbiturate
ONLINE DAT BARBITURATES PLUS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 29, 2004 |
| Received | Nov 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043211
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.