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510(k) K820396

AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR by Pheragen Technology Corp. — Product Code GKT

K820396 is an FDA 510(k) premarket notification submitted by Pheragen Technology Corp. for the device "AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR". The FDA issued a decision of Substantially Equivalent on April 27, 1982. The device falls under product code GKT (Separator, Automated, Blood Cell, Diagnostic), a Class II device regulated under 21 CFR 864.9245.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1982
Date Received
February 11, 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 for product code GKT

  • K200530 — AMICUS Separator System (September 11, 2020)
  • K162462 — AMICUS Separator System, AMICUS Separator System; Refurbished (November 23, 2016)
  • K822521 — AUTOMATED BLOOD CELL SEPARATOR (September 30, 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