FDA 510(k) Application Details - K132130

Device Classification Name	Reagent, Russel Viper Venom   More FDA Info for this Device
510(K) Number	K132130
Device Name	Reagent, Russel Viper Venom
Applicant	DSRV, INC. 780 PARK NORTH BLVD. SUITE 100 Clarkston, GA 30021 US Other 510(k) Applications for this Company
Contact	LAWANDA WASHINGTON 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	07/10/2013
Decision Date	01/10/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review