FDA 510(k) Application Details - K193475

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K193475
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	LifeScan Europe GmbH Gubelstrasse 34 Zug CH-6300 CH Other 510(k) Applications for this Company
Contact	Niki Skelly Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	NBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2019
Decision Date	02/14/2020
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