510(k) K133005

HEMOSIL VON WILLEBRAND ACTIVITY ASSAY by Instrumentation Laboratory CO — Product Code GGP

K133005 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL VON WILLEBRAND ACTIVITY ASSAY". The FDA issued a decision of Substantially Equivalent on March 13, 2014. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.