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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 K120759
Model GM505VAA
Device Name CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
Original Applicant
I-SENS, INC.
465-6 wolgye-dong, nowon-gu
seoul,  KS 139-845
Original Contact hyun joon oh
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received03/13/2012
Decision Date 06/05/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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