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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 K062770
Device Name COPILOT HEALTH MANAGEMENT SYSTEM
Applicant
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP RD.
ALAMEDA,  CA  94502
Applicant Contact MARY ROSE
Correspondent
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP RD.
ALAMEDA,  CA  94502
Correspondent Contact MARY ROSE
Regulation Number862.1345
Classification Product Code
NBW  
Date Received09/15/2006
Decision Date 12/14/2006
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
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