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Bionime Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K240637RIGHTEST Blood Glucose Monitoring System Max TelNovember 4, 2024
K231192RIGHTEST Blood Glucose Monitoring System Max TelJanuary 19, 2024
K221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceSeptember 26, 2022
K190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SBJune 2, 2019
K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE August 17, 2018
K173139Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz PlusJune 19, 2018
K170143GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood GlucoJuly 6, 2017
K161790iGlucose Blood Glucose Monitoring SystemMay 2, 2017
K140210RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720August 22, 2014
K133003RIGHTEST CONTROL SOLUTIONOctober 24, 2013
K123008RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOJanuary 25, 2013
K120423BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650August 3, 2012
K110737RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700March 29, 2012
K113007BIONIME DIABETES MANAGEMENT SYSTEM VI.0February 27, 2012
K092052RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550June 18, 2010
K081451RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100September 18, 2008
K081450RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110September 11, 2008
K072054RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310February 28, 2008
K062567RIGHTEST BLOOD GLUCOSE MONITORING SYSTEMFebruary 16, 2007
K053635MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEMFebruary 21, 2006