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510(k) K822521

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

K822521 is an FDA 510(k) premarket notification submitted by Cryosan, Inc. for the device "AUTOMATED BLOOD CELL SEPARATOR". The FDA issued a decision of Substantially Equivalent on September 30, 1982. The device falls under product code GKT (Separator, Automated, Blood Cell, Diagnostic), a Class II device regulated under 21 CFR 864.9245. Cryosan, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1982
Date Received
August 23, 1982
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 Cryosan, Inc.

  • K831953 — INFUSION PUMP (July 19, 1983)
  • K830831 — AUTOMATED BLOOD CELL SEPARATOR (June 16, 1983)
  • K813489 — ROCKING/CIRCULATING CYTO-THERM II 3570 (March 4, 1982)
  • K812311 — CIRCULATING CYTO-THERMS (September 16, 1981)
  • K812309 — CRYOSAN NORMAL SALINE (September 16, 1981)

Other clearances for product code GKT

  • K200530 — AMICUS Separator System (September 11, 2020)
  • K162462 — AMICUS Separator System, AMICUS Separator System; Refurbished (November 23, 2016)
  • 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)

FDA data resources