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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 K140371
Device Name FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)
Applicant
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP ROAD
ALAMEDA,  CA  94502
Applicant Contact MICHELLE RICAFORT
Correspondent
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP ROAD
ALAMEDA,  CA  94502
Correspondent Contact MICHELLE RICAFORT
Regulation Number862.1345
Classification Product Code
NBW  
Date Received02/14/2014
Decision Date 09/30/2014
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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