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510(k) K890849

HEMATASTAT H-70 by Separation Technology, Inc. — Product Code GKG

K890849 is an FDA 510(k) premarket notification submitted by Separation Technology, Inc. for the device "HEMATASTAT H-70". The FDA issued a decision of Substantially Equivalent on March 21, 1989. The device falls under product code GKG (Centrifuge, Hematocrit), a Class II device regulated under 21 CFR 864.6400. Separation Technology, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1989
Date Received
February 21, 1989
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 by Separation Technology, Inc.

  • K913128 — HEMATASTAT C-70B (September 23, 1991)

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)
  • 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