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U.S. Department of Health and Human Services

510(k) Premarket Notification
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111 to 120 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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alinity c ict sample diluent Abbott Laboratories K170320 10/24/2017
alinity h-series system Abbott Laboratories K220031 08/04/2023
alinity i total b-hcg reagent kit, alinity c glucose reagent kit, alinity c ict sample diluent, alinity ci-series Abbott Laboratories K230790 05/19/2023
alinity i total ß-hcg reagent kit, alinity i system ABBOTT LABORATORIES K170317 10/23/2017
alinity i total ß-hcg reagent kit, glp systems track Abbott Laboratories K230937 06/05/2023
architect 25-oh vitamin d 5p02, architect 25-oh vitamin d 5p02 calibrators, architect 25-oh vitamin d 5p02 controls ABBOTT LABORATORIES K153375 08/12/2016
architect 2nd generation testosterone Abbott Laboratories K152155 12/17/2015
architect b12 ABBOTT LABORATORIES K121314 05/17/2012
architect b12 calibrators ABBOTT LABORATORIES K053330 12/16/2005
architect b12 reagents, architect b12 calibrators, and architect b12 controls ABBOTT LABORATORIES K110579 10/06/2011

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