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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 22 Results
ProductCode: GKZ Applicant: ABBOTT LABORATORIES Decision Date To: 12/03/2022
 
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cell-dyn emerald 22 al system Abbott Laboratories K190294 03/15/2019
cell-dyn emerald 22 system ABBOTT LABORATORIES K110381 12/22/2011
cell-dyn emerald system ABBOTT LABORATORIES K081495 02/04/2009
cell-dyn ruby system ABBOTT LABORATORIES K061667 07/10/2006
cell-dyn sapphire system ABBOTT LABORATORIES K051215 07/21/2005
cell-dyn 1800 system ABBOTT LABORATORIES K030513 05/12/2003
cell-dyn 3200 system with absolute and percent reticulocyte ABBOTT LABORATORIES K012934 09/28/2001
cell-dyn 4000 immuno t-cell (cd3/4/8) assay ABBOTT LABORATORIES K010953 06/06/2001
modification of: cell-dyn 1200 system ABBOTT LABORATORIES K992444 09/24/1999
cell-dyn 3500 system with immature reticulocyte fraction (irf), cell-dyn 3700 system with immature reticulocyte fraction ABBOTT LABORATORIES K991605 07/09/1999
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