510(k) K872761

CELL-DYN 610 HEMATOLOGY ANALYZER by Abbott Diagnostics — Product Code GKZ

K872761 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics for the device "CELL-DYN 610 HEMATOLOGY ANALYZER". The FDA issued a decision of Substantially Equivalent on August 6, 1987. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Abbott Diagnostics has at least 10 other 510(k) clearances on record.