510(k) K895210 ยท DKZ Enzyme Immunoassay, Amphetamine
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 25, 1989 |
| Received | Aug 18, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895210
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.