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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K192859
Device Name CareSens S Clear BT Blood Glucose Monitoring System
Applicant
I-Sens, Inc.
43, Banpo-Daero 28-Gil
Seocho-Gu
Seoul,  KR 06646
Applicant Contact Joon Ho Jung
Correspondent
I-Sens, Inc.
43, Banpo-Daero 28-Gil
Seocho-Gu
Seoul,  KR 06646
Correspondent Contact Joon Ho Jung
Regulation Number862.1345
Classification Product Code
NBW  
Date Received10/04/2019
Decision Date 01/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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