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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK160179
Test Name VIVACHEK LABORATORIES, INC. VivaChek Ino Blood Glucose Monitoring System  
Manufacturer NameVIVACHEK LABORATORIES, INC.
Consumer Information Phone Number1(800)951-8430
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date04/24/2017
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K160179
Device Name VivaChek Ino Blood Glucose Monitoring System
Applicant
VIVACHEK LABORATORIES, INC.
913 N MARKET STREET
SUITE 200
Wilmington,  DE  19081
Applicant Contact Julie Zhou
Correspondent
VIVACHEK LABORATORIES, INC.
913 N MARKET STREET
SUITE 200
Wilmington,  DE  19081
Correspondent Contact Julie Zhou
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received01/27/2016
Decision Date 04/21/2017
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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