510(k) K000462 ยท LCM Enzyme Immunoassay, Phencyclidine
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 6, 2000 |
| Received | Feb 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000462
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.