510(k) K855116

SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM by Toa Medical Electronics USA, Inc. — Product Code GKZ

K855116 is an FDA 510(k) premarket notification submitted by Toa Medical Electronics USA, Inc. for the device "SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 24, 1986. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Toa Medical Electronics USA, Inc. has at least 10 other 510(k) clearances on record.