510(k) K981341 ยท DJG Enzyme Immunoassay, Opiates
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, May 22, 1998 |
| Received | Apr 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981341
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.