FDA 510(k) Application Details - K120466

Device Classification Name	Drug Metabolizing Enzyme Genotyping Systems   More FDA Info for this Device
510(K) Number	K120466
Device Name	Drug Metabolizing Enzyme Genotyping Systems
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	862.3360   More FDA Info for this Regulation Number
Classification Product Code	NTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2012
Decision Date	11/06/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review