510(k) K912679

DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN) by Baxter Healthcare Corp — Product Code GJT

K912679 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)". The FDA issued a decision of Substantially Equivalent on Sep 10, 1991. The device falls under product code GJT (Plasma, Coagulation Factor Deficient), a Class II device regulated under 21 CFR 864.7290. Baxter Healthcare Corp has 507 other 510(k) clearances on record.