FDA 510(k) Application Details - K070804

Device Classification Name	Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System   More FDA Info for this Device
510(K) Number	K070804
Device Name	Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Applicant	NANOSPHERE, INC 4088 COMMERCIAL AVENUE NORTHBROOK, IL 60062 US Other 510(k) Applications for this Company
Contact	SUE KENT Other 510(k) Applications for this Contact
Regulation Number	862.3360   More FDA Info for this Regulation Number
Classification Product Code	ODW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2007
Decision Date	09/17/2007
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