510(k) K852371

CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY by Abbott Diagnostics — Product Code GKZ

K852371 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics for the device "CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY". The FDA issued a decision of Substantially Equivalent on September 17, 1985. 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.