FDA 510(k) Application Details - K112113

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K112113
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	Roche Diagnostics 9115 HAGUE ROAD INDIANAPOLIS, IN 46250-0416 US Other 510(k) Applications for this Company
Contact	KELLY COLLEEN O'MAINE ADAMS Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2011
Decision Date	09/14/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review