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U.S. Department of Health and Human Services

510(k) Premarket Notification
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101 to 110 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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abbott architect total t4 calibrators ABBOTT LABORATORIES K151566 07/10/2015
abbott axsym b12 ABBOTT LABORATORIES K051327 08/03/2005
abbott axsym troponin-i adv ABBOTT LABORATORIES K041811 09/10/2004
abbott axsym troponin-i adv ABBOTT LABORATORIES K060875 06/14/2006
abbott immunoassay/clinical chemistry single analyte quality control materials (assayed) and abbott estradiol calibrator ABBOTT LABORATORIES K041687 08/18/2004
abbott lipid multi constituent calibrator ABBOTT LABORATORIES K123372 01/14/2013
abbott plex-id flu assay ABBOTT LABORATORIES K121003 12/21/2012
accelerator aps ABBOTT LABORATORIES K093318 02/19/2010
activated aspartate aminotransferase ABBOTT LABORATORIES K071525 03/19/2008
alinity c glucose reagent kit, alinity c system Abbott Laboratories K170316 10/19/2017

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