510(k) K021241

SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I by Sysmex Corporation of America — Product Code GKZ

K021241 is an FDA 510(k) premarket notification submitted by Sysmex Corporation of America for the device "SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I". The FDA issued a decision of Substantially Equivalent on June 25, 2002. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Sysmex Corporation of America has at least 2 other 510(k) clearances on record.