510(k) K213211 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
| Applicant | Carolina Liquid Chemistries Corp., Greensboro NC, US |
| Decision | Substantially Equivalent, Jan 27, 2022 |
| Received | Sep 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213211
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.