510(k) K974534 ยท MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites
MICRO-PLATE COTININE EIA
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, May 18, 1998 |
| Received | Dec 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974534
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.