510(k) K101059 ยท LCM Enzyme Immunoassay, Phencyclidine
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE
| Applicant | Omega Laboratories, Inc., South Lyon MI, US |
| Decision | Substantially Equivalent, Jul 12, 2010 |
| Received | Apr 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101059
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.