FDA 510(k) Application Details - DEN130002

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130002
Device Name	TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
Applicant	Roche Diagnostics 9115 SOUTH HAGUE ROAD INDIANAPOLIS, IN 46250 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	03/25/2013
Decision Date	05/23/2013
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review