510(k) K874210 ยท DIS Enzyme Immunoassay, Barbiturate
REVISED LABELING FOR ABUSCREEN EIA BARBITURATE
| Applicant | Roche Diagnostic Systems, Inc., Nutley NJ, US |
| Decision | Substantially Equivalent, Nov 13, 1987 |
| Received | Oct 16, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874210
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.