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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 K022580
Device Name BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Becton, Dickinson & CO
1 Becton Dr.
Franklin Lakes,  NJ  07417 -1885
Applicant Contact PETER ZURLO
Correspondent
Becton, Dickinson & CO
1 Becton Dr.
Franklin Lakes,  NJ  07417 -1885
Correspondent Contact PETER ZURLO
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received08/05/2002
Decision Date 10/09/2002
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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