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510(k) K915441

MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE by Fisher Scientific Co., LLC — Product Code GKF

K915441 is an FDA 510(k) premarket notification submitted by Fisher Scientific Co., LLC for the device "MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE". The FDA issued a decision of Substantially Equivalent on January 8, 1992. The device falls under product code GKF (Instrument, Hematocrit, Automated), a Class II device regulated under 21 CFR 864.5600. Fisher Scientific Co., LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1992
Date Received
December 4, 1991
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 Fisher Scientific Co., LLC

  • K930415 — MICROHEMATOCRIT ROTOR (March 23, 1993)
  • K915825 — MARATHON 6K GENERAL-PURPOSE CENTRIFUGE (March 11, 1992)
  • K890534 — MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 (March 8, 1989)
  • K881275 — URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II (May 16, 1988)
  • K874054 — FISHER DIAGNOSTICS HEMATALL III LAS REAGENT (October 20, 1987)
  • K872916 — HISTOMATIC SLIDE STAINER, CODE-ON VERSION (September 14, 1987)
  • K871058 — SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) (April 6, 1987)
  • K863224 — HEMATALL-C PLUS HEMATOLOGY CONTROLS (October 29, 1986)
  • K862318 — FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR (July 10, 1986)
  • K861185 — THERACHEM-PLUS, TRI-LEVEL TDC (TM) (May 23, 1986)

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)
  • K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR (December 27, 1990)
  • K880373 — IONOMETER E-HK AND ACCESSORIES (March 17, 1988)
  • K870860 — CHEMPRO 1000(TM) (April 14, 1987)

FDA data resources