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510(k) K192150

AMICUS Separator System by Fresenius Kabi AG — Product Code LKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2019
Date Received
August 9, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

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Other clearances for product code LKN

  • K183081 — Spectra Optia Apheresis System (February 5, 2019)
  • K180615 — AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, (December 4, 2018)
  • K181049 — Spectra Optia Apheresis System (November 1, 2018)
  • K172590 — Spectra Optia Apheresis System (March 2, 2018)
  • K153601 — Spectra Optia Apheresis System (January 14, 2016)
  • K151368 — Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), (September 11, 2015)
  • K141938 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUB (March 23, 2015)
  • K141019 — AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED (June 10, 2014)
  • K132429 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXC (December 6, 2013)
  • K131744 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA O (August 8, 2013)