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U.S. Department of Health and Human Services

510(k) Premarket Notification

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91 to 100 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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cholesterol2 Abbott Ireland Diagnostics Division K203597 06/30/2022
creatinine2 Abbott Ireland Diagnostics Division K210452 03/22/2022
total bilirubin2 Abbott Ireland Diagnostics Division K223324 12/29/2022
urea nitrogen2 Abbott Ireland Diagnostics Division K203771 05/31/2022
abbott architect estradiol calibrators; abbott imx estradiol calibrator; abbott imx estradiol mode 1 calibrator; abbott ABBOTT LABORATORIES K032458 10/06/2003
abbott architect free t3 Abbott Laboratories K170160 02/15/2017
abbott architect free t4 ABBOTT LABORATORIES K123379 11/27/2012
abbott architect free t4 Abbott Laboratories K173122 10/27/2017
abbott architect havab-m ABBOTT LABORATORIES K063329 04/16/2007
abbott architect lh calibrators ABBOTT LABORATORIES K111023 06/10/2011

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