Andon Health Co, Ltd. - FDA 510(k) Cleared Devices
92
Total
92
Cleared
0
Denied
FDA 510(k) cleared devices by Andon Health Co, Ltd. Chemistry ✕
9 devices
Cleared
Dec 20, 2024
iHealth® Early Pregnancy Test
Chemistry
218d
Cleared
Feb 01, 2019
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
Chemistry
284d
Cleared
Sep 15, 2017
iHealth Align Gluco-Monitoring System (BG1)
Chemistry
233d
Cleared
Feb 16, 2017
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose...
Chemistry
430d
Cleared
Aug 19, 2016
Wireless Smart Gluco-Monitoring System
Chemistry
281d
Cleared
Aug 19, 2016
iHealth Align Gluco-Monitoring system
Chemistry
281d
Cleared
Dec 04, 2015
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart...
Chemistry
249d
Cleared
May 22, 2014
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
Chemistry
164d
Cleared
Jul 21, 2008
AG-605 BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
269d