510(k) K960669

HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS by Morax — Product Code CFF

K960669 is an FDA 510(k) premarket notification submitted by Morax for the device "HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS". The FDA issued a decision of Substantially Equivalent on July 12, 1996. The device falls under product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Morax has at least 10 other 510(k) clearances on record.