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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 K022581
Device Name BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
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 Codes
CGA   JJX  
Date Received08/05/2002
Decision Date 10/09/2002
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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