510(k) K093989 ยท LCM Enzyme Immunoassay, Phencyclidine
ORAL FLUID PHENCYCLIDINE
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 25, 2011 |
| Received | Dec 24, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093989
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.