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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 K181273
Device Name GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System
Applicant
I-Sens, Inc.
43, Banpo-Daero 82-Gil, Seocho-Gu
Seoul,  KR 06646
Applicant Contact Joon Ho Jung
Correspondent
I-Sens, Inc.
43, Banpo-Daero 82-Gil, Seocho-Gu
Seoul,  KR 06646
Correspondent Contact Joon Ho Jung
Regulation Number862.1345
Classification Product Code
NBW  
Date Received05/14/2018
Decision Date 11/01/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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