510(k) K983174 ยท JXM Enzyme Immunoassay, Benzodiazepine
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Nov 18, 1998 |
| Received | Sep 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983174
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.