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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 K093930
Model 82411276
Device Name DIDGET WORLD REPORTS
Original Applicant
BAYER HEALTHCARE LLC
777 old saw mill river road
tarrytown,  NY  10591
Original Contact susan brocchi
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received12/22/2009
Decision Date 03/12/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Clinical Trials NCT00923975
Reviewed by Third Party No
Expedited Review No
Combination Product No
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