510(k) K942087

BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES by Biopool AB — Product Code GGP

K942087 is an FDA 510(k) premarket notification submitted by Biopool AB for the device "BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES". The FDA issued a decision of Substantially Equivalent on July 13, 1995. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Biopool AB has at least 10 other 510(k) clearances on record.