510(k) K050661

HEMOSIL FACTOR II DEFICIENT PLASMA by Instrumentation Laboratory CO — Product Code GJT

K050661 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL FACTOR II DEFICIENT PLASMA". The FDA issued a decision of Substantially Equivalent on May 2, 2005. The device falls under product code GJT (Plasma, Coagulation Factor Deficient), a Class II device regulated under 21 CFR 864.7290. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.