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510(k) K955795

MULTI-CENTRIFUGE by Novonx, Inc. — Product Code GKG

K955795 is an FDA 510(k) premarket notification submitted by Novonx, Inc. for the device "MULTI-CENTRIFUGE". The FDA issued a decision of Substantially Equivalent on March 29, 1996. The device falls under product code GKG (Centrifuge, Hematocrit), a Class II device regulated under 21 CFR 864.6400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1996
Date Received
December 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuge, Hematocrit
Device Class
Class II
Regulation Number
864.6400
Review Panel
HE
Submission Type

Other clearances for product code GKG

  • K961803 — SPUNCRIT (MODEL DRC-40) (July 5, 1996)
  • K930415 — MICROHEMATOCRIT ROTOR (March 23, 1993)
  • K925863 — SPUNCRIT (February 5, 1993)
  • K920207 — HERMLE Z230H (June 9, 1992)
  • K920759 — CRITSPIN MICRO-HEMATOCRIT (April 29, 1992)
  • K913128 — HEMATASTAT C-70B (September 23, 1991)
  • K890849 — HEMATASTAT H-70 (March 21, 1989)
  • K821803 — QBC CENTRIFUGAL HEMATOLOGY SYSTEM (September 14, 1982)
  • K822445 — HCT CENTRIFUGE (September 14, 1982)
  • K813033 — CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY (April 9, 1982)

FDA data resources