510(k) K012329

WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 by Wiener Laboratories Saic — Product Code CIX

K012329 is an FDA 510(k) premarket notification submitted by Wiener Laboratories Saic for the device "WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300". The FDA issued a decision of Substantially Equivalent on September 21, 2001. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Wiener Laboratories Saic has at least 10 other 510(k) clearances on record.