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510(k) K841956

BOVINE THROMBIN, HUMAN THROMBIN by Haemachem, Inc. — Product Code GJA

K841956 is an FDA 510(k) premarket notification submitted by Haemachem, Inc. for the device "BOVINE THROMBIN, HUMAN THROMBIN". The FDA issued a decision of Substantially Equivalent on July 19, 1984. The device falls under product code GJA (Test, Thrombin Time), a Class II device regulated under 21 CFR 864.7875. 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, Thrombin Time
Device Class
Class II
Regulation Number
864.7875
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)
  • K841957 — BOVINE FACTOR XA-HUMAN FACTOR XA (July 19, 1984)

Other clearances for product code GJA

  • K050817 — T-TEK (December 12, 2005)
  • K982209 — ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 (October 15, 1998)
  • K970645 — BC THROMBIN REAGENT (May 19, 1997)
  • K925493 — BIOMERIEUX HEMOLAB THROMBICALCI-TEST (April 21, 1994)
  • K930157 — TEST THROMBIN (May 14, 1993)
  • K923220 — THROMBIN CLOT TIME TEST PROCEDURE (September 29, 1992)
  • K920147 — THROMBIN CLOTTING TIME REAGENT (May 1, 1992)
  • K900126 — TT AND HNTT BY HEMOCHRON (February 5, 1990)
  • K894467 — THROMBIN TIME REAGENT (September 5, 1989)
  • K884385 — FIBRI-PREST/THROMBIN-PREST CONTROLS (December 28, 1988)

FDA data resources