510(k) K961435

MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE by Dako Corp. — Product Code GKZ

K961435 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN 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.