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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 K231192
Device Name RIGHTEST Blood Glucose Monitoring System Max Tel
Applicant
Bionime Corporation
# 100, Sec. 2 Daqing St., S. Dist.
Taichung City,  TW 40242
Applicant Contact Yu chi Huang
Correspondent
Dynamic Biotech, Inc. Dba. Ivdd Regulatory Consultant
29122 Rancho Viejo Rd., Suite 212
San Juan,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number862.1345
Classification Product Code
NBW  
Date Received04/27/2023
Decision Date 01/19/2024
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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