510(k) K992918 ยท DKZ Enzyme Immunoassay, Amphetamine
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Apr 3, 2000 |
| Received | Aug 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992918
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.