510(k) K132722

HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) by Instrumentation Laboratory CO — Product Code GJS

K132722 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)". The FDA issued a decision of Substantially Equivalent on January 22, 2014. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.