510(k) K172604

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

K172604 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "XW-100 Automated Hematology Analyzer for CLIA Waived Use". The FDA issued a decision of Substantially Equivalent on November 6, 2017. 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.