510(k) K954188

OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL by Immunotech Corp. — Product Code GKZ

K954188 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL". The FDA issued a decision of Substantially Equivalent on November 3, 1995. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Immunotech Corp. has at least 10 other 510(k) clearances on record.