Hypoguard USA, Inc. is one of 23863 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Hypoguard USA, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001, ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002, ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
9
Total
9
Cleared
0
Denied
Hypoguard USA, Inc. has 9 FDA 510(k) cleared medical devices. Based in Edina, US.
Historical record: 9 cleared submissions from 2001 to 2006. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Hypoguard USA, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Hypoguard USA, Inc.
9 devices
Cleared
Mar 28, 2006
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
Chemistry
146d
Cleared
Oct 04, 2005
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
Chemistry
118d
Cleared
Mar 25, 2005
ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
Chemistry
256d
Cleared
Mar 02, 2004
DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K),...
Chemistry
82d
Cleared
May 22, 2003
MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
20d
Cleared
Mar 28, 2003
EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
88d
Cleared
Oct 11, 2002
GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
Chemistry
71d
Cleared
Feb 12, 2002
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
29d
Cleared
Sep 11, 2001
DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00
Chemistry
162d