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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 K161790
Device Name iGlucose Blood Glucose Monitoring System
Applicant
Bionime Corporation
# 100, Sec. 2 Daqing St., S. Dist.
Taichung City,  TW 40242
Applicant Contact Tino Lee
Correspondent
Medical Device Regulatory Consultants
627 16th Ave.
Menlo Park,  CA  94025
Correspondent Contact Nina Peled
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received06/29/2016
Decision Date 05/02/2017
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
Predetermined Change
Control Plan Authorized		 No
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