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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 23 Results
ProductCode: NBW Applicant: ABBOTT DIABETES CARE INC. Decision Date To: 09/28/2022
 
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freestyle libre 2 flash glucose monitoring system (with freestyle libre 2 app) Abbott Diabetes Care Inc. K210943 11/22/2021
freestyle libre 2 flash glucose monitoring system (with freestyle libre 2 app) Abbott Diabetes Care Inc. K201761 07/30/2021
freestyle libre 2 flash glucose monitoring system Abbott Diabetes Care Inc. K193371 06/12/2020
freestyle precision neo blood glucose test strips Abbott Diabetes Care Inc. K171941 09/27/2017
freestyle precision neo h blood glucose monitoring system Abbott Diabetes Care Inc. K153330 02/19/2016
freestyle precision neo blood glucose: monitoring system, test strips (50ct), test strips (100ct) ABBOTT DIABETES CARE INC. K140371 09/30/2014
freestyle precision pro blood glucose and b-ketone monitoring system ABBOTT DIABETES CARE INC. K132511 12/24/2013
freestyle insulinx blood glucose monitoring system ABBOTT DIABETES CARE INC. K120568 03/29/2012
freestyle blood glucose test strips, models 100-count: 12401-01, 12101-21, 12101-22, 12101-23 ABBOTT DIABETES CARE INC. K092638 06/15/2010
freestyle lite blood glucose monitoring system and freestyle freedom lite blood glucose monitoring system ABBOTT DIABETES CARE INC. K092602 05/14/2010
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