510(k) K071779

ABX PENTRA URINE CAL by Horiba Abx — Product Code JIX

K071779 is an FDA 510(k) premarket notification submitted by Horiba Abx for the device "ABX PENTRA URINE CAL". The FDA issued a decision of Substantially Equivalent on March 5, 2008. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Horiba Abx has at least 10 other 510(k) clearances on record.