Home / 510(k) Clearances / K833892

510(k) K833892

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

K833892 is an FDA 510(k) premarket notification submitted by Kabivitrum, Inc. for the device "COATEST FACTOR VIII". The FDA issued a decision of Substantially Equivalent on January 30, 1984. 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
January 30, 1984
Date Received
November 9, 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)
  • K832114 — COATEST FACTOR X (August 26, 1983)
  • 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