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510(k) K833891

COATEST HEPARIN by Kabivitrum, Inc. — Product Code KFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
November 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Heparin
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

Other clearances by Kabivitrum, Inc.

  • K884058 — COATEST PROTEIN C (December 13, 1988)
  • K854572 — COATEST PLASMINOGEN (February 26, 1986)
  • K844664 — THE I.V. BAG (May 6, 1985)
  • K833890 — COATEST ANTIPLASMIN (January 30, 1984)
  • K833892 — COATEST FACTOR VIII (January 30, 1984)
  • K832114 — COATEST FACTOR X (August 26, 1983)
  • K812829 — COATEST ANTITHROMBIN (December 30, 1981)

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