Bionime Corporation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Bionime Corporation has 21 FDA 510(k) cleared chemistry devices. Based in Great Neck, US.
Latest FDA clearance: Nov 2024. Active since 2005.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Dynamic Biotech, Inc. Dba. Ivdd Regulatory Consultant and Symbiosis Consulting , Ltd..
FDA 510(k) Regulatory Record - Bionime Corporation
21 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
Sep 26, 2022
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
General & Plastic Surgery
168d
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
Cleared
Feb 27, 2012
BIONIME DIABETES MANAGEMENT SYSTEM VI.0
Chemistry
143d
Cleared
Jun 18, 2010
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550
Chemistry
346d
Cleared
Sep 18, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100
Chemistry
118d
Cleared
Sep 11, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110
Chemistry
111d
Cleared
Feb 28, 2008
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310
Chemistry
217d
Cleared
Feb 16, 2007
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
169d
Cleared
Feb 21, 2006
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
54d
Cleared
Jan 03, 2005
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
96d