FDA 510(k) Application Details - DEN120014

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN120014
Device Name	VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
Applicant	NANOSPHERE, INC 4088 COMMERCIAL AVENUE NORTHBROOK, IL 60062 US Other 510(k) Applications for this Company
Contact	MARK DEL VECCHIO Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2012
Decision Date	06/26/2012
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review