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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 19 Results
ProductCode: JJE Applicant: ABBOTT LABORATORIES Decision Date To: 11/27/2022
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glp systems track Abbott Laboratories K213486 03/10/2022
alinity i total ß-hcg reagent kit, alinity i system ABBOTT LABORATORIES K170317 10/23/2017
alinity c glucose reagent kit, alinity c system Abbott Laboratories K170316 10/19/2017
accelerator aps ABBOTT LABORATORIES K093318 02/19/2010
abbott architect testosterone ABBOTT LABORATORIES K983212 11/18/1998
aeroset system ABBOTT LABORATORIES K980367 04/01/1998
abbott alcyon(tm) 300 (without ise module) and 300i (with ise module) analyzer ABBOTT LABORATORIES K974779 02/13/1998
abbott axsym system ABBOTT LABORATORIES K974651 02/12/1998
abbott project i, spectrum ABBOTT LABORATORIES K945566 06/09/1995
abbott axsym ii system ABBOTT LABORATORIES K950915 05/16/1995