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510(k) K771258

BLOOD CELL SEPARATOR 2997 by Intl. Business Machines — Product Code GKT

K771258 is an FDA 510(k) premarket notification submitted by Intl. Business Machines for the device "BLOOD CELL SEPARATOR 2997". The FDA issued a decision of Substantially Equivalent on September 6, 1977. The device falls under product code GKT (Separator, Automated, Blood Cell, Diagnostic), a Class II device regulated under 21 CFR 864.9245. Intl. Business Machines has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1977
Date Received
July 12, 1977
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 Intl. Business Machines

  • K831004 — AUTOMATED 8400 BLOOD CELL SEPARATOR (September 12, 1983)
  • K830163 — IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS (February 18, 1983)
  • K812355 — IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 (September 9, 1981)
  • K810988 — IBM 5885 DIGITAL ECG ACQUISITION CART (May 1, 1981)
  • K810989 — IBM 5880 ACQUISITION & ANALYSIS CART TEL (May 1, 1981)
  • K772353 — EKG ACQUISITION & ANALYSIS CART (January 6, 1978)
  • K760856 — BLOOD CELL PROCESSOR MODEL 2 IBM 2991 (January 10, 1977)

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)
  • 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)
  • K760856 — BLOOD CELL PROCESSOR MODEL 2 IBM 2991 (January 10, 1977)

FDA data resources