ClearanceBrief
510(k) K231290 · DFH Kappa, Antigen, Antiserum, Control

Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit

ApplicantThe Binding Site, Ltd., Birmingham, GB
DecisionSubstantially Equivalent, Jan 24, 2024
ReceivedMay 4, 2023
TypeTraditional
FDA recordOpen 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.