FDA 510(k) Applications for Medical Device Product Code "GKT"
(Separator, Automated, Blood Cell, Diagnostic)

FDA 510(k) Number Applicant Device Name Decision Date
K200530 Fresenius Kabi AG AMICUS Separator System 09/11/2020
K162462 FRESENIUS KABI USA LLC AMICUS Separator System, AMICUS Separator System; Refurbished 11/23/2016


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