FDA 510(k) Application Details - K121610

Device Classification Name	More FDA Info for this Device
510(K) Number	K121610
Device Name	COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
Applicant	ROCHE DIAGNOSTICS OPERATIONS 9115 Hague Rd Indianapolis, IN 46256 US Other 510(k) Applications for this Company
Contact	Susan Hollandbeck Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2012
Decision Date	08/08/2013
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