510(k) K982551 ยท DIS Enzyme Immunoassay, Barbiturate
ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Aug 18, 1998 |
| Received | Jul 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982551
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.