510(k) K020371 ยท DJG Enzyme Immunoassay, Opiates
UPLINK TEST SYSTEM
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Apr 3, 2002 |
| Received | Feb 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020371
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.