510(k) K983697 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Dec 11, 1998 |
| Received | Oct 21, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K983697
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.