510(k) K964974

MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE by Dako Corp. — Product Code GKZ

K964974 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE". The FDA issued a decision of Substantially Equivalent on June 24, 1997. 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.