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GKT — Separator, Automated, Blood Cell, Diagnostic Class II

FDA Device Classification

Classification Details

Product Code
GKT
Device Class
Class II
Regulation Number
864.9245
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K200530fresenius kabiAMICUS Separator SystemSeptember 11, 2020
K162462fresenius kabi usaAMICUS Separator System, AMICUS Separator System; RefurbishedNovember 23, 2016
K822521cryosanAUTOMATED BLOOD CELL SEPARATORSeptember 30, 1982
K820396pheragen technologyAUTOMATED BLOOD CELL SEPAR. DISP. SFTWRApril 27, 1982
K801233travenol laboratoriesCELLTRIFUGE IIOctober 31, 1980
K791106travenol laboratoriesSTERILE, DISPOSABLE CENTRIFUGE BOWLAugust 10, 1979
K790105terumo americaTERUMO IMUGARDMay 24, 1979
K781803metrix teknikaFILTER, EYRPUR DISPOSABLE LEUKOCITEJanuary 17, 1979
K771258intl. business machinesBLOOD CELL SEPARATOR 2997September 6, 1977
K760856intl. business machinesBLOOD CELL PROCESSOR MODEL 2 IBM 2991January 10, 1977