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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 K040628
Device Name PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
Applicant
Abbott Laboratories
4-A Crosby Dr.
Bedford,  MA  01730
Applicant Contact GRAHAM BAILLIE
Correspondent
Abbott Laboratories
4-A Crosby Dr.
Bedford,  MA  01730
Correspondent Contact GRAHAM BAILLIE
Regulation Number862.1345
Classification Product Code
NBW  
Date Received03/10/2004
Decision Date 03/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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