510(k) K974611 ยท DKZ Enzyme Immunoassay, Amphetamine
MICRO-STRIP FOR AMPHETAMINE METABOLITES
| Applicant | Microdiagnostics, Inc., Laguna Niguel CA, US |
| Decision | Substantially Equivalent, Mar 20, 1998 |
| Received | Dec 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974611
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.