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510(k) K864039

MICROHEMATOCRIT CENTRIFUGE by Plaza Medical, Inc. — Product Code GKF

K864039 is an FDA 510(k) premarket notification submitted by Plaza Medical, Inc. for the device "MICROHEMATOCRIT CENTRIFUGE". The FDA issued a decision of Substantially Equivalent on October 29, 1986. The device falls under product code GKF (Instrument, Hematocrit, Automated), a Class II device regulated under 21 CFR 864.5600.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1986
Date Received
October 16, 1986
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 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