510(k) K991440 ยท DIS Enzyme Immunoassay, Barbiturate
ROCHE COBAS INTEGRA SERUM BARBITURATES
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 22, 1999 |
| Received | Apr 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991440
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.