510(k) K243283

Alinity h-series System by Abbott Laboratories — Product Code GKZ

K243283 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "Alinity h-series System". The FDA issued a decision of Substantially Equivalent on February 20, 2025. 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.