510(k) K955909

MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE by Dako Corp. — Product Code GKZ

K955909 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE". The FDA issued a decision of Substantially Equivalent on March 28, 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.