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510(k) K841957

BOVINE FACTOR XA-HUMAN FACTOR XA by Haemachem, Inc. — Product Code GGP

K841957 is an FDA 510(k) premarket notification submitted by Haemachem, Inc. for the device "BOVINE FACTOR XA-HUMAN FACTOR XA". The FDA issued a decision of Substantially Equivalent on July 19, 1984. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Haemachem, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1984
Date Received
May 14, 1984
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 Haemachem, Inc.

  • K903874 — FIBRINOTEST(TM) - FIBRINOGEN ASSAY (February 14, 1991)
  • K853239 — HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY (November 5, 1985)
  • K841956 — BOVINE THROMBIN, HUMAN THROMBIN (July 19, 1984)

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