510(k) K960187 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
COCAINE METABOLITE EIA TEST
| Applicant | Diagnostic Reagents, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 2, 1996 |
| Received | Jan 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960187
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2013 | Microgenics Corp DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories.
100 ml, IVD
Mfg by:
Microgenics Corporation,
46360 Fremont Blvd.
Fremont, CA 94538
The DRI Cocaine Metabolit Terminated |
DIO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.