ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H

About This 510(k) Submission

K072115 is an FDA 510(k) clearance for the ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on November 30, 2007, 121 days after receiving the submission on August 1, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.