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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K103278
Device Name ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION
Applicant
I-Sens, Inc.
465-6 Wolgye-Dong, Nowon-Gu
Seoul,  KR 139-845
Applicant Contact HYUN JOON OH
Correspondent
I-Sens, Inc.
465-6 Wolgye-Dong, Nowon-Gu
Seoul,  KR 139-845
Correspondent Contact HYUN JOON OH
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received11/05/2010
Decision Date 10/28/2011
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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