Medical Device Manufacturer · US , Edina , MN

Hypoguard USA, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2001

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

View 9 510(k) Devices ↓

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hypoguard USA, Inc. Chemistry ✕

9 devices

1-9 of 9

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