FDA 510(k) Application Details - K163633

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K163633
Device Name	Assay, Glycosylated Hemoglobin
Applicant	Roche Diagnostics Operations 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Patty Bates Other 510(k) Applications for this Contact
Regulation Number	864.7470   More FDA Info for this Regulation Number
Classification Product Code	LCP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2016
Decision Date	07/28/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review