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510(k) K162462

AMICUS Separator System, AMICUS Separator System; Refurbished by Fresenius Kabi USA,Llc — Product Code GKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2016
Date Received
September 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Separator, Automated, Blood Cell, Diagnostic
Device Class
Class II
Regulation Number
864.9245
Review Panel
HE
Submission Type

Other clearances by Fresenius Kabi USA,Llc

  • K180615 — AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, (December 4, 2018)

Other clearances for product code GKT

  • K200530 — AMICUS Separator System (September 11, 2020)
  • K822521 — AUTOMATED BLOOD CELL SEPARATOR (September 30, 1982)
  • K820396 — AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR (April 27, 1982)
  • K801233 — CELLTRIFUGE II (October 31, 1980)
  • K791106 — STERILE, DISPOSABLE CENTRIFUGE BOWL (August 10, 1979)
  • K790105 — TERUMO IMUGARD (May 24, 1979)
  • K781803 — FILTER, EYRPUR DISPOSABLE LEUKOCITE (January 17, 1979)
  • K771258 — BLOOD CELL SEPARATOR 2997 (September 6, 1977)
  • K760856 — BLOOD CELL PROCESSOR MODEL 2 IBM 2991 (January 10, 1977)