Home / 510(k) Clearances / K830831

510(k) K830831

AUTOMATED BLOOD CELL SEPARATOR by Cryosan, Inc. — Product Code LKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1983
Date Received
March 16, 1983
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

Other clearances by Cryosan, Inc.

  • K831953 — INFUSION PUMP (July 19, 1983)
  • K822521 — AUTOMATED BLOOD CELL SEPARATOR (September 30, 1982)
  • K813489 — ROCKING/CIRCULATING CYTO-THERM II 3570 (March 4, 1982)
  • K812311 — CIRCULATING CYTO-THERMS (September 16, 1981)
  • K812309 — CRYOSAN NORMAL SALINE (September 16, 1981)

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  • 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)