510(k) K981197 ยท DKZ Enzyme Immunoassay, Amphetamine
ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST
| Applicant | Tcpi, Inc., Ft. Lauderdale FL, US |
| Decision | Substantially Equivalent, Jun 16, 1998 |
| Received | Apr 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981197
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.