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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 K022545
Device Name GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
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
JQP  
Date Received08/01/2002
Decision Date 10/11/2002
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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