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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K051514
Device Name ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
Original Applicant
HYPOGUARD USA, INC.
5182 west 76th st.
minneapolis,  MN  55439
Original Contact bruce a macfarlane
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received06/08/2005
Decision Date 10/04/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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