510(k) K143483

MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING by Sebia — Product Code CFF

K143483 is an FDA 510(k) premarket notification submitted by Sebia for the device "MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING". The FDA issued a decision of Substantially Equivalent on January 8, 2015. 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.