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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 K120568
Device Name FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
Applicant
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP RD.
ALAMEDA,  CA  94502
Applicant Contact ARUL STERLIN
Correspondent
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP RD.
ALAMEDA,  CA  94502
Correspondent Contact ARUL STERLIN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received02/27/2012
Decision Date 03/29/2012
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
Recalls CDRH Recalls
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