510(k) K983698 ยท DIS Enzyme Immunoassay, Barbiturate
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, May 3, 1999 |
| Received | Oct 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983698
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.