510(k) K952182

OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES by Immunotech, Inc. — Product Code GKZ

K952182 is an FDA 510(k) premarket notification submitted by Immunotech, Inc. for the device "OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES". The FDA issued a decision of Substantially Equivalent on July 5, 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.