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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 K173139
Device Name Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
Applicant
Bionime Corporation
No. 100, Sec. 2, Daqing St., South Dist.
Taichung,  TW 40242
Applicant Contact Kay Wu
Correspondent
Dynamic Biotech Inc. dba IVDD Regulatory Consultant
29222 Rancho Viejo Road, Suite 218
San Juan Capistrano,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number862.1345
Classification Product Code
NBW  
Date Received09/29/2017
Decision Date 06/19/2018
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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