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U.S. Department of Health and Human Services

510(k) Premarket Notification

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61 to 70 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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510(K)
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freestyle libre 2 flash glucose monitoring system Abbott Diabetes Care Inc. K193371 06/12/2020
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 (with freestyle libre 2 app) Abbott Diabetes Care Inc. K210943 11/22/2021
freestyle libre 2 flash glucose monitoring system; freestyle libre 3 continuous glucose monitoring system Abbott Diabetes Care Inc. K222447 03/03/2023
freestyle libre 2 system, freestyle libre 3 system Abbott Diabetes Care Inc. K223537 02/21/2023
freestyle libre 3 continuous glucose monitoring system Abbott Diabetes Care Inc. K212132 05/26/2022
freestyle libre 3 continuous glucose monitoring system Abbott Diabetes Care Inc. K213996 05/26/2022
freestyle libre 3 continuous glucose monitoring system; freestyle libre 2 flash glucose monitoring system Abbott Diabetes Care Inc. K223435 04/13/2023
freestyle libre 3 continuous glucose monitoring system; freestyle libre 2 flash glucose monitoring system Abbott Diabetes Care Inc. K233537 04/23/2024
freestyle lite blood glucose monitoring system ABBOTT DIABETES CARE INC. K070850 04/10/2007

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