FDA 510(k) Application Details - K170316

Device Classification Name	Hexokinase, Glucose   More FDA Info for this Device
510(K) Number	K170316
Device Name	Hexokinase, Glucose
Applicant	Abbott Laboratories Dept. 09AA, Bldg CP1-3, 100 Abbott Park Road Abbott Park, IL 60064 US Other 510(k) Applications for this Company
Contact	Noah Lermer 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	02/01/2017
Decision Date	10/19/2017
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