510(k) K842537

VON WILLEBRAND FACTOR ANTIGEN SCREEN by American Dade — Product Code ICF

K842537 is an FDA 510(k) premarket notification submitted by American Dade for the device "VON WILLEBRAND FACTOR ANTIGEN SCREEN". The FDA issued a decision of Substantially Equivalent on October 1, 1984. The device falls under product code ICF (Crystal Violet For Histology), a Class I device regulated under 21 CFR 864.1850. American Dade has at least 10 other 510(k) clearances on record.