510(k) K200033

HemosIL von Willebrand Factor Antigen by Instrumentation Laboratory CO — Product Code GGP

K200033 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HemosIL von Willebrand Factor Antigen". The FDA issued a decision of Substantially Equivalent on August 19, 2020. 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.