510(k) K080431 ยท LCM Enzyme Immunoassay, Phencyclidine
RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054
| Applicant | Quantrx Biomedical Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Jan 8, 2009 |
| Received | Feb 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080431
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.