HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS

About This 510(k) Submission

K960669 is an FDA 510(k) clearance for the HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS, a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II — Special Controls, product code CFF), submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on July 12, 1996, 143 days after receiving the submission on February 20, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.