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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 K040814
Device Name MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
Applicant
ABBOTT LABORATORIES
4-A CROSBY DR.
BEDFORD,  MA  01730 -1402
Applicant Contact TRACEY H WIELINSKI
Correspondent
ABBOTT LABORATORIES
4-A CROSBY DR.
BEDFORD,  MA  01730 -1402
Correspondent Contact TRACEY H WIELINSKI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JIN   LFR  
Date Received03/30/2004
Decision Date 04/15/2004
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
Recalls CDRH Recalls
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