510(k) K081378 ยท DJR Enzyme Immunoassay, Methadone
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
| Applicant | Thermo Fisher Scientific, Fremont Blvd. CA, US |
| Decision | Substantially Equivalent, Jan 14, 2009 |
| Received | May 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081378
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.