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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK083468
Test Name Fifty 50 Medical, Fifty 50 Glucose Monitoring System 2.0  
Manufacturer NameI-Sens, Inc.
Consumer Information Phone Number1(800)746-7505
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date10/14/2009
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K083468
Device Name CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)
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
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received11/24/2008
Decision Date 02/10/2009
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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