FDA 510(k) Application Details - K193053

Device Classification Name	More FDA Info for this Device
510(K) Number	K193053
Device Name	Tina-quant Hemoglobin A1cDx Gen.3
Applicant	Roche Diagnostics Operations (RDO) 9115 Hague Rd Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Leslie Patterson 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	11/01/2019
Decision Date	03/26/2020
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