Bionime Corporation - FDA 510(k) Cleared Devices
Recent clearances: RIGHTEST Blood Glucose Monitoring System Max Tel, RIGHTEST Blood Glucose Monitoring System Max Tel, RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bionime Corporation Chemistry ✕
20 devices
Cleared
Nov 04, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
Chemistry
243d
Cleared
Jan 19, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
Chemistry
267d
Cleared
Jun 02, 2019
Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose...
Chemistry
89d
Cleared
Aug 17, 2018
Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose...
Chemistry
266d
Cleared
Jun 19, 2018
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose...
Chemistry
263d
Cleared
Jul 06, 2017
GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System...
Chemistry
170d
Cleared
May 02, 2017
iGlucose Blood Glucose Monitoring System
Chemistry
307d
Cleared
Aug 22, 2014
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS...
Chemistry
206d
Cleared
Oct 24, 2013
RIGHTEST CONTROL SOLUTION
Chemistry
29d
Cleared
Jan 25, 2013
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE...
Chemistry
120d
Cleared
Aug 03, 2012
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650
Chemistry
172d
Cleared
Mar 29, 2012
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700
Chemistry
379d