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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 K100937
Device Name PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
Applicant
I-Sens, Inc.
465-6 Wolgye-Dong, Nowon-Gu
Seoul,  KR 139-845
Applicant Contact HYUN OH
Correspondent
I-Sens, Inc.
465-6 Wolgye-Dong, Nowon-Gu
Seoul,  KR 139-845
Correspondent Contact HYUN OH
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received04/05/2010
Decision Date 12/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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