510(k) K953498

OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL by Immunotech, Inc. — Product Code GKZ

K953498 is an FDA 510(k) premarket notification submitted by Immunotech, Inc. for the device "OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Immunotech, Inc. has at least 10 other 510(k) clearances on record.