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510(k) K160415

GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) by Instrumentation Laboratory CO — Product Code GKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2016
Date Received
February 12, 2016
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

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Other clearances for product code GKF

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  • 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)
  • K870860 — CHEMPRO 1000(TM) (April 14, 1987)