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510(k) K903874

FIBRINOTEST(TM) - FIBRINOGEN ASSAY by Haemachem, Inc. — Product Code GIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1991
Date Received
August 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Fibrinogen
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
Submission Type

Other clearances by Haemachem, Inc.

  • K853239 — HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY (November 5, 1985)
  • K841956 — BOVINE THROMBIN, HUMAN THROMBIN (July 19, 1984)
  • K841957 — BOVINE FACTOR XA-HUMAN FACTOR XA (July 19, 1984)

Other clearances for product code GIS

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  • K042919 — FIBROTEK FIB (November 29, 2004)
  • K993482 — K-ASSAY FIBRINOGEN (December 6, 1999)
  • K963902 — QUANTITATIVE FIBRINOGEN ASSAY (November 29, 1996)
  • K941001 — ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT (August 30, 1994)
  • K925494 — BIOMERIEUX HEMOLAB FIBRINOMAT (May 18, 1993)
  • K923921 — IL TEST PT FIBRINOGEN HS (October 26, 1992)
  • K913061 — FIBRINOGEN DETERMINATION KIT (October 9, 1991)
  • K910636 — ABS CADKIT (April 29, 1991)
  • K881685 — FIBRINOGENTEST-O (August 9, 1988)