510(k) K141161

ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) by HORIBA ABX SAS — Product Code GKZ

K141161 is an FDA 510(k) premarket notification submitted by HORIBA ABX SAS for the device "ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)". The FDA issued a decision of Substantially Equivalent on December 20, 2014. 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.