510(k) K854368

CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER by Abbott Diagnostics — Product Code GKZ

K854368 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics for the device "CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER". The FDA issued a decision of Substantially Equivalent on January 1, 1986. 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.