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510(k) K920207

HERMLE Z230H by Labnet Intl., Inc. — Product Code GKG

K920207 is an FDA 510(k) premarket notification submitted by Labnet Intl., Inc. for the device "HERMLE Z230H". The FDA issued a decision of Substantially Equivalent on June 9, 1992. 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
June 9, 1992
Date Received
January 16, 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

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)
  • K925863 — SPUNCRIT (February 5, 1993)
  • 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