510(k) K161928

CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL by Sebia — Product Code CFF

K161928 is an FDA 510(k) premarket notification submitted by Sebia for the device "CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL". The FDA issued a decision of Substantially Equivalent on December 21, 2016. The device falls under product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Sebia has at least 10 other 510(k) clearances on record.