510(k) K072115

ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H by Horiba Abx — Product Code CGX

K072115 is an FDA 510(k) premarket notification submitted by Horiba Abx for the device "ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H". The FDA issued a decision of Substantially Equivalent on November 30, 2007. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. Horiba Abx has at least 10 other 510(k) clearances on record.