ClearanceBrief
510(k) K210623 ยท DFH Kappa, Antigen, Antiserum, Control

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2

ApplicantSebia, Norcross GA, US
DecisionSubstantially Equivalent, Nov 18, 2022
ReceivedMar 2, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K210623

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.