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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 K062058
Device Name ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
Original Applicant
BAYER HEALTHCARE
430 south beiger street
mishawaka,  IN  46544
Original Contact roger sonnenberg
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received07/20/2006
Decision Date 09/11/2006
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
Recalls CDRH Recalls
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