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510(k) K832114

COATEST FACTOR X by Kabivitrum, Inc. — Product Code GGP

K832114 is an FDA 510(k) premarket notification submitted by Kabivitrum, Inc. for the device "COATEST FACTOR X". The FDA issued a decision of Substantially Equivalent on August 26, 1983. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Kabivitrum, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1983
Date Received
June 30, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Qualitative And Quantitative Factor Deficiency
Device Class
Class II
Regulation Number
864.7290
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)
  • K833891 — COATEST HEPARIN (January 30, 1984)
  • K833890 — COATEST ANTIPLASMIN (January 30, 1984)
  • K833892 — COATEST FACTOR VIII (January 30, 1984)
  • K812829 — COATEST ANTITHROMBIN (December 30, 1981)

Other clearances for product code GGP

  • K251440 — CRYOcheck Chromogenic Factor VIII (August 25, 2025)
  • K230852 — HemosIL Chromogenic Factor IX (December 13, 2023)
  • K220728 — vWF Ag (June 2, 2023)
  • K214002 — CRYOcheck Chromogenic Factor IX (December 23, 2022)
  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K200033 — HemosIL von Willebrand Factor Antigen (August 19, 2020)
  • K193204 — Cryocheck Chromogenic Factor VIII (July 17, 2020)
  • K183440 — CRYOcheck FVIII Inhibitor Kit (March 12, 2019)
  • K181525 — INNOVANCE Free PS Ag (September 7, 2018)
  • K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (March 13, 2014)

FDA data resources