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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 K070850
Device Name FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
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  
Date Received03/28/2007
Decision Date 04/10/2007
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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