510(k) K982831 ยท JXM Enzyme Immunoassay, Benzodiazepine
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Nov 12, 1998 |
| Received | Aug 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982831
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.