FDA 510(k) Application Details - K191899

Device Classification Name	Hexokinase, Glucose   More FDA Info for this Device
510(K) Number	K191899
Device Name	Hexokinase, Glucose
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Khoa Tran Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	CFR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2019
Decision Date	08/16/2019
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