Home / 510(k) Clearances / K781803

510(k) K781803

FILTER, EYRPUR DISPOSABLE LEUKOCITE by Metrix Teknika, Inc. — Product Code GKT

K781803 is an FDA 510(k) premarket notification submitted by Metrix Teknika, Inc. for the device "FILTER, EYRPUR DISPOSABLE LEUKOCITE". The FDA issued a decision of Substantially Equivalent on January 17, 1979. The device falls under product code GKT (Separator, Automated, Blood Cell, Diagnostic), a Class II device regulated under 21 CFR 864.9245. Metrix Teknika, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1979
Date Received
October 23, 1978
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 Metrix Teknika, Inc.

  • K781802 — WASHER SYSTEM, MICROELISA (December 20, 1978)
  • K781348 — FOCISCAN ECHOVISOR SYSTEM (October 3, 1978)
  • K780035 — MINIVISOR (March 6, 1978)

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)
  • K771258 — BLOOD CELL SEPARATOR 2997 (September 6, 1977)
  • K760856 — BLOOD CELL PROCESSOR MODEL 2 IBM 2991 (January 10, 1977)

FDA data resources