510(k) K190294

CELL-DYN Emerald 22 AL System by Abbott Laboratories — Product Code GKZ

K190294 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "CELL-DYN Emerald 22 AL System". The FDA issued a decision of Substantially Equivalent on March 15, 2019. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Abbott Laboratories has at least 10 other 510(k) clearances on record.