510(k) K181135 ยท LCM Enzyme Immunoassay, Phencyclidine
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
| Applicant | Immunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, Jan 24, 2019 |
| Received | Apr 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181135
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.