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Bionime Corporation

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories2
Latest FDA decision2024-11-04
TypeNumberDevice NameCodeDateActions
510(k) K240637 RIGHTEST Blood Glucose Monitoring System Max TelNBW2024-11-04 View
510(k) K231192 RIGHTEST Blood Glucose Monitoring System Max TelNBW2024-01-19 View
510(k) K221062 RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceQRL2022-09-26 View
510(k) K190564 Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SBNBW2019-06-02 View
510(k) K173638 Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max PlusNBW2018-08-17 View
510(k) K173139 Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz PlusNBW2018-06-19 View
510(k) K170143 GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,NBW2017-07-06 View
510(k) K161790 iGlucose Blood Glucose Monitoring SystemNBW2017-05-02 View