510(k) K982801 ยท LCM Enzyme Immunoassay, Phencyclidine
AUTO-LYTE PCP EIA, MODEL #1254U
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Nov 4, 1998 |
| Received | Aug 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982801
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.