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510(k) K953519

MICROSPIN 24 by Vulcon Technologies — Product Code GKF

K953519 is an FDA 510(k) premarket notification submitted by Vulcon Technologies for the device "MICROSPIN 24". The FDA issued a decision of Substantially Equivalent on November 3, 1995. 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
November 3, 1995
Date Received
July 27, 1995
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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  • K981425 — STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS (May 12, 1998)
  • K981427 — STAT PROFILE M ANALYZER (May 12, 1998)
  • K981426 — STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS (May 12, 1998)
  • 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)

FDA data resources