510(k) K960531

MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE by Dako Corp. — Product Code GKZ

K960531 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE". The FDA issued a decision of Substantially Equivalent on June 14, 1996. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Dako Corp. has at least 10 other 510(k) clearances on record.