FDA 510(k) Application Details - K103221

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K103221
Device Name	Calibrator, Secondary
Applicant	Roche Diagnostics 9115 HAGUE ROAD P.O. BOX 50416 INDIANAPOLIS, IN 46250-0416 US Other 510(k) Applications for this Company
Contact	KELLY C O'MAINE ADAMS Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2010
Decision Date	12/23/2010
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