510(k) K813044

ULTRACHEM ALB, ITEM #64970 by Harleco — Product Code CIX

K813044 is an FDA 510(k) premarket notification submitted by Harleco for the device "ULTRACHEM ALB, ITEM #64970". The FDA issued a decision of Substantially Equivalent on November 10, 1981. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Harleco has at least 10 other 510(k) clearances on record.