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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 28 Results
ProductCode: JJX Applicant: ABBOTT LABORATORIES Decision Date To: 05/17/2024
 
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architect 25-oh vitamin d 5p02, architect 25-oh vitamin d 5p02 calibrators, architect 25-oh vitamin d 5p02 controls ABBOTT LABORATORIES K153375 08/12/2016
architect syphilis tp reagent, architect syphilis tp calibrator, architect syphilis tp control Abbott Laboratories K153730 06/15/2016
hemoglobin a1c assay, hemoglobin a1c calibrators, hemoglobin a1c controls ABBOTT LABORATORIES K140654 05/22/2015
hemoglobin a1c, hemoglobin a1c calibrators, hemoglobin a1c controls ABBOTT LABORATORIES K130255 02/28/2014
abbott architect free t4 ABBOTT LABORATORIES K123379 11/27/2012
testosterone test system; calibrator; and quality control material (assayed and unassayed) ABBOTT LABORATORIES K120009 09/11/2012
architect b12 ABBOTT LABORATORIES K121314 05/17/2012
architect b12 reagents, architect b12 calibrators, and architect b12 controls ABBOTT LABORATORIES K110579 10/06/2011
architect folate reagents, architect folate calibrators, and architect folate controls, models 1p74, 1p74, 1p74 ABBOTT LABORATORIES K092740 03/05/2010
axsym digoxin iii ABBOTT LABORATORIES K061249 06/02/2006
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