510(k) K253212

XR-Series (XR-10, XR-20) Automated Hematology Analyzers by Sysmex America, Inc. — Product Code GKZ

K253212 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "XR-Series (XR-10, XR-20) Automated Hematology Analyzers". The FDA issued a decision of Substantially Equivalent on May 27, 2026. 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.