ClearanceBrief
510(k) K250549 · DFH Kappa, Antigen, Antiserum, Control

Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit

ApplicantThe Binding Site Group , Ltd., Birmingham, GB
DecisionSubstantially Equivalent, May 23, 2025
ReceivedFeb 25, 2025
TypeTraditional
FDA recordOpen 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.