510(k) K123171

ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT by HORIBA ABX SAS — Product Code CJY

K123171 is an FDA 510(k) premarket notification submitted by HORIBA ABX SAS for the device "ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT". The FDA issued a decision of Substantially Equivalent on July 3, 2013. The device falls under product code CJY (Azo Dye, Calcium), a Class II device regulated under 21 CFR 862.1145. HORIBA ABX SAS has at least 10 other 510(k) clearances on record.