510(k) K000399 ยท LCM Enzyme Immunoassay, Phencyclidine
STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, May 15, 2000 |
| Received | Feb 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000399
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.