510(k) K870354

IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) by American Dade — Product Code GGP

K870354 is an FDA 510(k) premarket notification submitted by American Dade for the device "IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)". The FDA issued a decision of Substantially Equivalent on February 10, 1987. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. American Dade has at least 10 other 510(k) clearances on record.