510(k) K945692

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910) by Dako Corp. — Product Code GKZ

K945692 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)". The FDA issued a decision of Substantially Equivalent on January 25, 1995. 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.