510(k) K082388

MINICAP IMMUNOTYPING, MODEL: 2300 by Sebia — Product Code CFF

K082388 is an FDA 510(k) premarket notification submitted by Sebia for the device "MINICAP IMMUNOTYPING, MODEL: 2300". The FDA issued a decision of Substantially Equivalent on April 14, 2009. 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.