510(k) K024162

SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 by Helena Laboratories — Product Code CFF

K024162 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389". The FDA issued a decision of Substantially Equivalent on February 19, 2003. 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.