Company ยท US
Bionime Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2024. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 4, 2024 | K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel Bionime Corporation, TW | NBW |
| Jan 19, 2024 | K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel Bionime Corporation, TW | NBW |
| Sep 26, 2022 | K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device Bionime Corporation, TW | QRL |
| Jun 2, 2019 | K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB Bionime Corporation, TW | NBW |
| Aug 17, 2018 | K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monito Bionime Corporation, TW | NBW |
| Jun 19, 2018 | K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus Bionime Corporation, TW | NBW |
| Jul 6, 2017 | K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System Bionime Corporation, TW | NBW |
| May 2, 2017 | K161790 | iGlucose Blood Glucose Monitoring System Bionime Corporation, TW | NBW |
| Aug 22, 2014 | K140210 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 Bionime Corporation | NBW |
| Oct 24, 2013 | K133003 | RIGHTEST CONTROL SOLUTION Bionime Corporation | JJX |
| Jan 25, 2013 | K123008 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN Bionime Corporation | NBW |
| Aug 3, 2012 | K120423 | BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 Bionime Corporation | NBW |
| Mar 29, 2012 | K110737 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 Bionime Corporation | NBW |
| Feb 27, 2012 | K113007 | BIONIME DIABETES MANAGEMENT SYSTEM VI.0 Bionime Corporation | JQP |
| Jun 18, 2010 | K092052 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 Bionime Corporation | NBW |
| Sep 18, 2008 | K081451 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 Bionime Corporation | NBW |
| Sep 11, 2008 | K081450 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 Bionime Corporation | NBW |
| Feb 28, 2008 | K072054 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 Bionime Corporation | NBW |
| Feb 16, 2007 | K062567 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM Bionime Corporation | NBW |
| Feb 21, 2006 | K053635 | MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM Bionime Corporation | NBW |
| Jan 3, 2005 | K042678 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM Bionime Corporation | NBW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||