510(k) K203489 ยท LCM Enzyme Immunoassay, Phencyclidine
SEFRIA PCP Oral Fluid Enzyme Immunoassay
| Applicant | Immunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, Apr 20, 2021 |
| Received | Nov 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203489
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.