FDA 510(k) Application Details - K103171

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K103171
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50416 INDIANAPOLIS, IN 46250-0416 US Other 510(k) Applications for this Company
Contact	Sarah Baumann Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2010
Decision Date	02/11/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review