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510(k) K925863

SPUNCRIT by bioMerieux, Inc. — Product Code GKG

K925863 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "SPUNCRIT". The FDA issued a decision of Substantially Equivalent on February 5, 1993. The device falls under product code GKG (Centrifuge, Hematocrit), a Class II device regulated under 21 CFR 864.6400. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1993
Date Received
November 19, 1992
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

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Other clearances for product code GKG

  • K961803 — SPUNCRIT (MODEL DRC-40) (July 5, 1996)
  • K955795 — MULTI-CENTRIFUGE (March 29, 1996)
  • K930415 — MICROHEMATOCRIT ROTOR (March 23, 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