510(k) K060434

ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL by Horiba Abx — Product Code CIX

K060434 is an FDA 510(k) premarket notification submitted by Horiba Abx for the device "ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL". The FDA issued a decision of Substantially Equivalent on June 5, 2007. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Horiba Abx has at least 10 other 510(k) clearances on record.