510(k) K081890

SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER by Sysmex America, Inc. — Product Code GKZ

K081890 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER". The FDA issued a decision of Substantially Equivalent on October 10, 2008. 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.