Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
FDA 510(k) cleared devices by Roche Diagnostics Corp. General Hospital ✕
4 devices
Cleared
Aug 27, 2010
ACCU-CHEK ULTRFLEX INFUSION SET
General Hospital
120d
Cleared
May 15, 2008
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
General Hospital
106d
Cleared
Sep 13, 2005
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
General Hospital
173d
Cleared
Apr 08, 2005
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
General Hospital
108d