510(k) K002010 ยท DJR Enzyme Immunoassay, Methadone
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Nov 29, 2000 |
| Received | Jul 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002010
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.