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U.S. Department of Health and Human Services

510(k) Premarket Notification
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121 to 130 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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architect cmv igg Abbott Laboratories K220949 10/27/2022
architect folate reagents, architect folate calibrators, and architect folate controls, models 1p74, 1p74, 1p74 ABBOTT LABORATORIES K092740 03/05/2010
architect havab-g ABBOTT LABORATORIES K113704 06/28/2012
architect icarbamazepine icarbamazepine reagents; architect icarbamazepine calibrators ABBOTT LABORATORIES K103627 10/14/2011
architect igentamicin reagents; architect igentamicin calibrators ABBOTT LABORATORIES K102699 04/01/2011
architect iphenobarbital reagents and architect iphenobarbital calibrators, models 1p33, 1p33 ABBOTT LABORATORIES K081231 09/26/2008
architect iphenytoin reagents and architech iphenytoin calibrators with models 1p34, and 1p34-01 ABBOTT LABORATORIES K080696 09/11/2008
architect syphilis tp reagent, architect syphilis tp calibrator, architect syphilis tp control Abbott Laboratories K153730 06/15/2016
architect total bilirubin ABBOTT LABORATORIES K121985 02/01/2013
architect toxo igg Abbott Laboratories K210596 05/19/2022

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