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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 K023219
Device Name BECTON DICKINSON DIABETES SOFTWARE
Applicant
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Applicant Contact JOHN SCHALAGO
Correspondent
BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES,  NJ  07417 -1885
Correspondent Contact JOHN SCHALAGO
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received09/26/2002
Decision Date 12/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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