510(k) K141681

SYSMEX XN SERIES by Sysmex America, Inc. — Product Code GKZ

K141681 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "SYSMEX XN SERIES". The FDA issued a decision of Substantially Equivalent on December 5, 2014. 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.