510(k) K210623

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 by Sebia — Product Code DFH

K210623 is an FDA 510(k) premarket notification submitted by Sebia for the device "FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2". The FDA issued a decision of Substantially Equivalent on November 18, 2022. The device falls under product code DFH (Kappa, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Sebia has at least 10 other 510(k) clearances on record.