510(k) K944253

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 by Dako Corp. — Product Code GKZ

K944253 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25". The FDA issued a decision of Substantially Equivalent on November 21, 1994. 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.