510(k) K210346

Sysmex XW-100 Automated Hematology Analyzer by Sysmex America, Inc. — Product Code GKZ

K210346 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "Sysmex XW-100 Automated Hematology Analyzer". The FDA issued a decision of Substantially Equivalent on November 8, 2022. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Sysmex America, Inc. has at least 10 other 510(k) clearances on record.