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510(k) K822445

HCT CENTRIFUGE by Boehringer Mannheim Corp. — Product Code GKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1982
Date Received
August 16, 1982
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)
  • 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)
  • K813033 — CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY (April 9, 1982)