510(k) K231601

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

K231601 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 February 23, 2024. 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.