FDA 510(k) Application Details - K061805

Device Classification Name	Reagent, Russel Viper Venom   More FDA Info for this Device
510(K) Number	K061805
Device Name	Reagent, Russel Viper Venom
Applicant	DIAGNOSTICA STAGO, INC. 5 CENTURY DR. PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	LAURA WORFOLK Other 510(k) Applications for this Contact
Regulation Number	864.8950   More FDA Info for this Regulation Number
Classification Product Code	GIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2006
Decision Date	12/06/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review