510(k) K170353

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT by HORIBA ABX SAS — Product Code GKZ

K170353 is an FDA 510(k) premarket notification submitted by HORIBA ABX SAS for the device "ABX MICROS ES 60 OT and ABX MICROS ES 60 CT". The FDA issued a decision of Substantially Equivalent on November 1, 2017. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. HORIBA ABX SAS has at least 10 other 510(k) clearances on record.