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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 K130094
Device Name FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
Applicant
Abbott Diabetes Care
1360 S. Loop Rd.
Alameda,  CA  94502
Applicant Contact DAVID G LAMBERT
Correspondent
Abbott Diabetes Care
1360 S. Loop Rd.
Alameda,  CA  94502
Correspondent Contact DAVID G LAMBERT
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JIN   JQP   LFR  
Date Received01/10/2013
Decision Date 06/27/2013
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
Predetermined Change
Control Plan Authorized		 No
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