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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Applicant: ABBOTT LABORATORIES Decision Date To: 08/13/2022
 
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alinity i stat high sensitivity troponin-i Abbott Laboratories Diagnostics Division K202525 05/19/2022
architect toxo igg Abbott Laboratories K210596 05/19/2022
glp systems track Abbott Laboratories K213486 03/10/2022
i-stat tbi plasma cartridge with the i-stat alinity system Abbott Laboratories K201778 01/08/2021
architect stat high sensitivity troponin-i Abbott Laboratories Diagnostics Division K191595 09/13/2019
cell-dyn emerald 22 al system Abbott Laboratories K190294 03/15/2019
magnesium Abbott Laboratories K181748 09/12/2018
magnesium Abbott Laboratories K173294 05/18/2018
abbott architect free t4 Abbott Laboratories K173122 10/27/2017
alinity c ict sample diluent Abbott Laboratories K170320 10/24/2017

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