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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 K123089
Model PRT24238-001
Device Name FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
Original Applicant
ABBOTT LABORATORIES
1360 south loop road
alameda,  CA  94502
Original Contact david g lambert
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received11/02/2012
Decision Date 04/05/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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