510(k) K031829

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

K031829 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL FACTOR IX DEFICIENT PLASMA". The FDA issued a decision of Substantially Equivalent on July 31, 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.