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Hypoguard USA, Inc.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K053079 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001CGA2006-03-28 View
510(k) K051514 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002NBW2005-10-04 View
510(k) K041881 ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100CGA2005-03-25 View
510(k) K033851 DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)JIL2004-03-02 View
510(k) K031388 MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEMCGA2003-05-22 View
510(k) K024347 EXPRESS BLOOD GLUCOSE MONITORING SYSTEMCGA2003-03-28 View
510(k) K022545 GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020NBW2002-10-11 View
510(k) K020232 HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEMCGA2002-02-12 View
510(k) K010973 DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000JIL2001-09-11 View
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