510(k) K110031

HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM by Instrumentation Laboratory CO — Product Code GIR

K110031 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM". The FDA issued a decision of Substantially Equivalent on August 24, 2011. The device falls under product code GIR (Reagent, Russel Viper Venom), a Class I device regulated under 21 CFR 864.8950. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.