510(k) K061069

SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 by Helena Laboratories — Product Code CFF

K061069 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458". The FDA issued a decision of Substantially Equivalent on July 6, 2006. The device falls under product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Helena Laboratories has at least 10 other 510(k) clearances on record.