510(k) K131488

ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT by Alfa Wassermann Diagnostics Technologies, LLC — Product Code CIX

K131488 is an FDA 510(k) premarket notification submitted by Alfa Wassermann Diagnostics Technologies, LLC for the device "ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT". The FDA issued a decision of Substantially Equivalent on August 19, 2013. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Alfa Wassermann Diagnostics Technologies, LLC has at least 2 other 510(k) clearances on record.