FDA 510(k) Application Details - K160571

Device Classification Name	More FDA Info for this Device
510(K) Number	K160571
Device Name	cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
Applicant	Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	David Tribbett 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	02/29/2016
Decision Date	12/19/2016
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