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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 K040603
Device Name PARADIGM LINK BLOOD GLUCOSE METER
Original Applicant
BECTON DICKINSON & CO.
1 becton dr.
franklin lakes,  NJ  07417 1885
Original Contact john schalago
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received03/30/2004
Decision Date 05/19/2004
Decision substantially equivalent - CLIA submission (CS)
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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