Andon Medical Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM, AG-608N BLOOD GLUCOSE MONITORING SYSTEM
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Andon Medical Co., Ltd. Chemistry ✕
8 devices
Cleared
Apr 12, 2013
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
Chemistry
113d
Cleared
Dec 07, 2012
BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
263d
Cleared
CT
Jan 18, 2012
AG-608N BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
380d
Cleared
Sep 30, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
Chemistry
10d
Cleared
Aug 26, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI...
Chemistry
344d
Cleared
Aug 09, 2011
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
Chemistry
456d
Cleared
Jul 15, 2011
AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND...
Chemistry
585d
Cleared
Jul 13, 2010
AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING...
Chemistry
267d