510(k) K110530

ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL by HORIBA ABX SAS — Product Code CGX

K110530 is an FDA 510(k) premarket notification submitted by HORIBA ABX SAS for the device "ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL". The FDA issued a decision of Substantially Equivalent on April 30, 2012. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. HORIBA ABX SAS has at least 10 other 510(k) clearances on record.