Medical Device Manufacturer · US , Great Neck , NY

Bionime Corporation - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 2005
21
Total
21
Cleared
0
Denied

FDA 510(k) cleared devices by Bionime Corporation Chemistry

20 devices
1-20 of 20
Cleared Nov 04, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K240637 · NBW
Chemistry · 243d
Cleared Jan 19, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K231192 · NBW
Chemistry · 267d
Cleared Jun 02, 2019
Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose...
K190564 · NBW
Chemistry · 89d
Cleared Aug 17, 2018
Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose...
K173638 · NBW
Chemistry · 266d
Cleared Jun 19, 2018
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose...
K173139 · NBW
Chemistry · 263d
Cleared Jul 06, 2017
GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System...
K170143 · NBW
Chemistry · 170d
Cleared May 02, 2017
iGlucose Blood Glucose Monitoring System
K161790 · NBW
Chemistry · 307d
Cleared Aug 22, 2014
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS...
K140210 · NBW
Chemistry · 206d
Cleared Oct 24, 2013
RIGHTEST CONTROL SOLUTION
K133003 · JJX
Chemistry · 29d
Cleared Jan 25, 2013
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE...
K123008 · NBW
Chemistry · 120d
Cleared Aug 03, 2012
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650
K120423 · NBW
Chemistry · 172d
Cleared Mar 29, 2012
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700
K110737 · NBW
Chemistry · 379d
Cleared Feb 27, 2012
BIONIME DIABETES MANAGEMENT SYSTEM VI.0
K113007 · JQP
Chemistry · 143d
Cleared Jun 18, 2010
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550
K092052 · NBW
Chemistry · 346d
Cleared Sep 18, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100
K081451 · NBW
Chemistry · 118d
Cleared Sep 11, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110
K081450 · NBW
Chemistry · 111d
Cleared Feb 28, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310
K072054 · NBW
Chemistry · 217d
Cleared Feb 16, 2007
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K062567 · NBW
Chemistry · 169d
Cleared Feb 21, 2006
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K053635 · NBW
Chemistry · 54d
Cleared Jan 03, 2005
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K042678 · NBW
Chemistry · 96d
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