510(k) K982745 ยท DIS Enzyme Immunoassay, Barbiturate
AUTO-LYTE BARBITURATES EIA
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Nov 18, 1998 |
| Received | Aug 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982745
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.