510(k) K192517 ยท MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Psychemedics Microplate EIA for Cotinine in Hair
| Applicant | Psychemedics Corporation, Culver City CA, US |
| Decision | Substantially Equivalent, Apr 22, 2020 |
| Received | Sep 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192517
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.