FDA 510(k) Applications Submitted by Bionime Corporation
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140210 |
01/28/2014 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 |
BIONIME CORPORATION |
| K120423 |
02/13/2012 |
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 |
BIONIME CORPORATION |
| K113007 |
10/07/2011 |
BIONIME DIABETES MANAGEMENT SYSTEM VI.0 |
BIONIME CORPORATION |
| K110737 |
03/16/2011 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 |
BIONIME CORPORATION |
| K133003 |
09/25/2013 |
RIGHTEST CONTROL SOLUTION |
BIONIME CORPORATION |
| K123008 |
09/27/2012 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN |
BIONIME CORPORATION |
| K170143 |
01/17/2017 |
GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, |
Bionime Corporation |
| K173139 |
09/29/2017 |
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus |
Bionime Corporation |
| K173638 |
11/24/2017 |
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 Plus |
Bionime Corporation |
| K190564 |
03/05/2019 |
Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB |
Bionime Corporation |
| K081450 |
05/23/2008 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 |
BIONIME CORPORATION |
| K081451 |
05/23/2008 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 |
BIONIME CORPORATION |
| K092052 |
07/07/2009 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 |
BIONIME CORPORATION |
| K072054 |
07/26/2007 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 |
BIONIME CORPORATION |
| K062567 |
08/31/2006 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM |
BIONIME CORPORATION |
| K042678 |
09/29/2004 |
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM |
BIONIME CORPORATION |
| K053635 |
12/29/2005 |
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM |
BIONIME CORPORATION |
| K161790 |
06/29/2016 |
iGlucose Blood Glucose Monitoring System |
BIONIME CORPORATION |
| K221062 |
04/11/2022 |
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device |
Bionime Corporation |
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