510(k) K110137

ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN by HORIBA ABX SAS — Product Code JFY

K110137 is an FDA 510(k) premarket notification submitted by HORIBA ABX SAS for the device "ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN". The FDA issued a decision of Substantially Equivalent on August 10, 2011. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. HORIBA ABX SAS has at least 10 other 510(k) clearances on record.