510(k) K250549 · DFH Kappa, Antigen, Antiserum, Control
Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, May 23, 2025 |
| Received | Feb 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250549
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.