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510(k) K844664

THE I.V. BAG by Kabivitrum, Inc. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1985
Date Received
November 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

Other clearances by Kabivitrum, Inc.

  • K884058 — COATEST PROTEIN C (December 13, 1988)
  • K854572 — COATEST PLASMINOGEN (February 26, 1986)
  • K833892 — COATEST FACTOR VIII (January 30, 1984)
  • K833890 — COATEST ANTIPLASMIN (January 30, 1984)
  • K833891 — COATEST HEPARIN (January 30, 1984)
  • K832114 — COATEST FACTOR X (August 26, 1983)
  • K812829 — COATEST ANTITHROMBIN (December 30, 1981)

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