FDA 510(k) Application Details - K201394

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K201394
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu Seoul 06646 KR Other 510(k) Applications for this Company
Contact	Joon Ho Jung 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	05/27/2020
Decision Date	10/05/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
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