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U.S. Department of Health and Human Services

510(k) Premarket Notification
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81 to 90 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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freestyle libre 2 flash glucose monitoring system Abbott Diabetes Care, Inc. K211102 08/11/2021
id now covid-19 2.0 Abbott Diagnostics Scarborough, Inc. K221925 08/10/2023
id now influenza a & b 2 Abbott Diagnostics Scarborough, Inc. K191534 07/11/2019
id now influenza a & b 2 Abbott Diagnostics Scarborough, Inc. K232775 10/10/2023
id now instrument, id now influenza a & b 2, id now strep a 2 Abbott Diagnostics Scarborough, Inc. K220801 06/24/2022
afinion™ hba1c, afinion™ 2 and alere afinion™ as100 analyzer Abbott Diagnostics Technologies AS K214117 09/27/2023
albumin bcg2 Abbott Ireland Diagnostics Division K203248 11/23/2021
albumin bcp2 Abbott Ireland Diagnostics Division K203530 03/18/2022
alkaline phosphatase2 Abbott Ireland Diagnostics Division K223317 07/21/2023
amylase2 Abbott Ireland Diagnostics Division K210633 05/26/2022

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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