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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 K051839
Device Name FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
Applicant
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP RD.
ALAMEDA,  CA  94502
Applicant Contact DHRUMA SHAH
Correspondent
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP RD.
ALAMEDA,  CA  94502
Correspondent Contact DHRUMA SHAH
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received07/07/2005
Decision Date 03/09/2006
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
Recalls CDRH Recalls
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