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510(k) K781059

CUTTER/COMPUR MINI CENTRIFUGE by Cutter Laboratories, Inc. — Product Code GKF

K781059 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "CUTTER/COMPUR MINI CENTRIFUGE". The FDA issued a decision of Substantially Equivalent on August 14, 1978. The device falls under product code GKF (Instrument, Hematocrit, Automated), a Class II device regulated under 21 CFR 864.5600. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
June 26, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Hematocrit, Automated
Device Class
Class II
Regulation Number
864.5600
Review Panel
HE
Submission Type

Other clearances by Cutter Laboratories, Inc.

  • K861315 — HYPERBARIC PENETRATION EXTENSION SET (May 21, 1986)
  • K854106 — BAYSILEX (March 17, 1986)
  • K842324 — PERFOURM (November 9, 1984)
  • K834106 — INTRAVENOUS INFUSION CONTROLLER (May 30, 1984)
  • K832237 — ORTHOPEDIC CASTING TAPE MAXCAST (August 16, 1983)
  • K823214 — DOSIMETRIC RELEASE PROGRAM - ADMIN. SET (January 12, 1983)
  • K821326 — CUTTER BOND POLYCARBOXYLATE CEMENT (May 28, 1982)
  • K813532 — CUTTERBOND ZINC PHOSPHATE CEMENT (March 2, 1982)
  • K802105 — C-BLADE (September 16, 1980)
  • K802104 — C-SPLINT (September 16, 1980)

Other clearances for product code GKF

  • K160415 — GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemo (December 14, 2016)
  • K983551 — CRIT-SCAN II MONITOR (May 27, 1999)
  • K981427 — STAT PROFILE M ANALYZER (May 12, 1998)
  • K981426 — STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS (May 12, 1998)
  • K981425 — STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS (May 12, 1998)
  • K953519 — MICROSPIN 24 (November 3, 1995)
  • K915825 — MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (March 11, 1992)
  • K915441 — MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE (January 8, 1992)
  • K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR (December 27, 1990)
  • K880373 — IONOMETER E-HK AND ACCESSORIES (March 17, 1988)

FDA data resources