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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 K260689
Device Name CVS Advanced PLUS Blood Glucose Monitoring System
Applicant
I-Sens, Inc.
Banpo-Daero 28 Gil, 43
Seocho-Gu
Seoul,  KR 06646
Applicant Contact Jeong Soohyun
Correspondent
I-Sens, Inc.
Banpo-Daero 28 Gil, 43
Seocho-Gu
Seoul,  KR 06646
Correspondent Contact Jeong Soohyun
Regulation Number862.1345
Classification Product Code
NBW  
Date Received03/03/2026
Decision Date 10/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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