510(k) K953499 ยท DJR Enzyme Immunoassay, Methadone
AXSYM METHADONE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 13, 1995 |
| Received | Jul 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953499
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.