510(k) K973153 ยท DJG Enzyme Immunoassay, Opiates
UBI MAGIWEL AMPHETAMINE METABOLITES
| Applicant | United Biotech, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Oct 28, 1997 |
| Received | Aug 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973153
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.