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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Use Blood Lancet For Single Patient Use Only
510(k) Number K221062
Device Name RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
Applicant
Bionime Corporation
# 100 Section 2 Daqing St., S. District
Taichung City,  TW 40242
Applicant Contact Yu Chi Huang
Correspondent
Symbiosis Consulting , Ltd.
11f., #95, Sec. 2, Nanjing E. Rd., Zhongshan Dist.,
Taipei,  TW 10489
Correspondent Contact I Hsin Li
Regulation Number878.4850
Classification Product Code
QRL  
Date Received04/11/2022
Decision Date 09/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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