Arkray Factory USA, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ARK CARE DIABETES MANAGMENT SYSTEM, ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER), ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Arkray Factory USA, Inc. Chemistry ✕
9 devices
Cleared
May 19, 2011
ARK CARE DIABETES MANAGMENT SYSTEM
Chemistry
66d
Cleared
Jun 09, 2010
ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)
Chemistry
177d
Cleared
Nov 24, 2009
ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
133d
Cleared
Oct 23, 2009
ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
Chemistry
190d
Cleared
Oct 09, 2009
POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
212d
Cleared
Aug 14, 2009
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001
Chemistry
185d
Cleared
Oct 21, 2008
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110
Chemistry
60d
Cleared
Jun 13, 2008
ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM
Chemistry
193d
Cleared
Aug 09, 2007
GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
231d