FDA 510(k) Application Details - K000528

Device Classification Name	Reagent, Russel Viper Venom   More FDA Info for this Device
510(K) Number	K000528
Device Name	Reagent, Russel Viper Venom
Applicant	SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. ST. LOUIS, MO 63103 US Other 510(k) Applications for this Company
Contact	WILLIAM R GILBERT 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	02/17/2000
Decision Date	04/07/2000
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