510(k) K884020

COULTER CLONE B4 MONOCLONAL ANTIBODY by Coulter Immunology — Product Code GKZ

K884020 is an FDA 510(k) premarket notification submitted by Coulter Immunology for the device "COULTER CLONE B4 MONOCLONAL ANTIBODY". The FDA issued a decision of Substantially Equivalent on February 3, 1989. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Coulter Immunology has at least 10 other 510(k) clearances on record.