FDA 510(k) Application Details - K140083

Device Classification Name	More FDA Info for this Device
510(K) Number	K140083
Device Name	VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
Applicant	NANOSPHERE, INC 4088 COMMERCIAL AVENUE NORTHBROOK, IL 60062 US Other 510(k) Applications for this Company
Contact	Teresa Raich Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/2014
Decision Date	06/20/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review