510(k) K061805

STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM by Diagnostica Stago, Inc. — Product Code GIR

K061805 is an FDA 510(k) premarket notification submitted by Diagnostica Stago, Inc. for the device "STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM". The FDA issued a decision of Substantially Equivalent on December 6, 2006. The device falls under product code GIR (Reagent, Russel Viper Venom), a Class I device regulated under 21 CFR 864.8950. Diagnostica Stago, Inc. has at least 10 other 510(k) clearances on record.