510(k) K103788

PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT by HORIBA ABX SAS — Product Code CFR

K103788 is an FDA 510(k) premarket notification submitted by HORIBA ABX SAS for the device "PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT". The FDA issued a decision of Substantially Equivalent on November 8, 2011. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. HORIBA ABX SAS has at least 10 other 510(k) clearances on record.