510(k) K231290 · DFH Kappa, Antigen, Antiserum, Control
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
| Applicant | The Binding Site, Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Jan 24, 2024 |
| Received | May 4, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231290
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.