510(k) K023839

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

K023839 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL FACTOR V DEFICIENT PLASMA". The FDA issued a decision of Substantially Equivalent on January 14, 2003. 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.