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U.S. Department of Health and Human Services

510(k) Premarket Notification

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31 to 40 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 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
abbott architect stat troponin i liquid assayed cardiac marker control level l, m and h MEDICAL ANALYSIS SYSTEMS, INC. K041194 08/16/2004
abbott architect total t4 calibrators ABBOTT LABORATORIES K151566 07/10/2015
abbott axsym b-type natriuretic peptide (bnp) microparticle enzyme immunoassay (meia) test AXIS-SHIELD DIAGNOSTICS, LTD. K033606 01/30/2004
abbott axsym b12 ABBOTT LABORATORIES K051327 08/03/2005
abbott axsym testosterone microparticle enzyme immunoassay (meia) AXIS-SHIELD DIAGNOSTICS, LTD. K041866 09/29/2004

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