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Arkray Factory USA, Inc.

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

Total Devices9
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K110709 ARK CARE DIABETES MANAGMENT SYSTEMNBW2011-05-19 View
510(k) K093819 ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER)NBW2010-06-09 View
510(k) K092104 ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEMCGA2009-11-24 View
510(k) K091102 ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMSCGA2009-10-23 View
510(k) K090653 POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEMNBW2009-10-09 View
510(k) K090332 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001NBW2009-08-14 View
510(k) K082417 GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110CGA2008-10-21 View
510(k) K073416 ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEMCGA2008-06-13 View
510(k) K063771 GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEMNBW2007-08-09 View
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