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U.S. Department of Health and Human Services

OTC - Over The Counter

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Document NumberK160742
Test Name i-SENS, Inc. NoCoding1 Plus Blood Glucose Monitoring System  
Manufacturer Namei-SENS, INC.
Consumer Information Phone Number(800)429-5001
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date12/19/2016
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K160742
Device Name NoCoding1 Plus Blood Glucose Monitoring System
Applicant
i-SENS, INC.
43, BANPO-DAER0 28-GIL, SEOCHO-GU
SEOUL,  KR 06646
Applicant Contact Joon Ho Jung
Correspondent
i-SENS, INC.
43, BANPO-DAER0 28-GIL, SEOCHO-GU
SEOUL,  KR 06646
Correspondent Contact Joon Ho Jung
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received03/17/2016
Decision Date 12/16/2016
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
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