510(k) K882557

COULTER CLONE B1 MONOCLONAL ANTIBODY by Coulter Immunology — Product Code GKZ

K882557 is an FDA 510(k) premarket notification submitted by Coulter Immunology for the device "COULTER CLONE B1 MONOCLONAL ANTIBODY". The FDA issued a decision of Substantially Equivalent on September 14, 1988. 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.