510(k) K192299 ยท MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites
LZI Cotinine II Enzyme Immunoassay
| Applicant | Lin-Zhi International, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Nov 21, 2019 |
| Received | Aug 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192299
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.