FDA 510(k) Application Details - K111527

Device Classification Name	More FDA Info for this Device
510(K) Number	K111527
Device Name	MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
Applicant	ERAGEN BIOSCIENCES, INC. 918 Deming Way, Suite 201 Madison, WI 53717-1944 US Other 510(k) Applications for this Company
Contact	DAVID LIM Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2011
Decision Date	08/03/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review