510(k) K890491

CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER by Abbott Diagnostics — Product Code GKZ

K890491 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics for the device "CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER". The FDA issued a decision of Substantially Equivalent on April 18, 1989. 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.