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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K041478
Device Name BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
Applicant
Becton Dickinson
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact JOHN SCHALAGO
Correspondent
Becton Dickinson
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact JOHN SCHALAGO
Regulation Number862.1345
Classification Product Code
CGA  
Date Received06/03/2004
Decision Date 10/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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