510(k) K193124

Unicel DxH 800 Coulter Cellular Analysis System by Beckman Coulter — Product Code GKZ

K193124 is an FDA 510(k) premarket notification submitted by Beckman Coulter for the device "Unicel DxH 800 Coulter Cellular Analysis System". The FDA issued a decision of Substantially Equivalent on April 16, 2020. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Beckman Coulter has at least 10 other 510(k) clearances on record.