GJA · Class II · 21 CFR 864.7875

FDA Product Code GJA: Test, Thrombin Time

Leading manufacturers include General Diagnostics, Bio/Data Corp. and American Bioproducts Co..

20
Total
20
Cleared
103d
Avg days
1979
Since

FDA 510(k) Cleared Test, Thrombin Time Devices (Product Code GJA)

20 devices
1–20 of 20
Cleared Oct 15, 1998
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
K982209
Sigma Diagnostics, Inc.
Hematology · 114d
Cleared May 19, 1997
BC THROMBIN REAGENT
K970645
Behring Diagnostics, Inc.
Hematology · 88d
Cleared Apr 21, 1994
BIOMERIEUX HEMOLAB THROMBICALCI-TEST
K925493
Biomerieux Vitek, Inc.
Hematology · 535d
Cleared May 14, 1993
TEST THROMBIN
K930157
Behring Diagnostics, Inc.
Hematology · 121d
Cleared Sep 29, 1992
THROMBIN CLOT TIME TEST PROCEDURE
K923220
Medical Laboratory Automation Systems, Inc.
Hematology · 90d
Cleared May 01, 1992
THROMBIN CLOTTING TIME REAGENT
K920147
Helena Laboratories
Hematology · 109d
Cleared Feb 05, 1990
TT AND HNTT BY HEMOCHRON
K900126
International Technidyne Corp.
Hematology · 27d
Cleared Sep 05, 1989
THROMBIN TIME REAGENT
K894467
Sigma Chemical Co.
Hematology · 49d
Cleared Dec 28, 1988
THROMBIN-PREST REAGENT KIT
K884384
American Bioproducts Co.
Hematology · 71d
Cleared Dec 28, 1988
FIBRI-PREST/THROMBIN-PREST CONTROLS
K884385
American Bioproducts Co.
Hematology · 71d
Cleared Sep 03, 1986
IL SYSTEM 810, ACL AND THE REAGENT SETS
K862301
Instrumentation Laboratory CO
Hematology · 78d
Cleared Mar 26, 1985
THROMBINEX BOVINE THROMBIN
K845000
Bio/Data Corp.
Hematology · 90d
Cleared Feb 04, 1984
THROMBOLYTIC ACTIVITY TEST
K834301
Bio/Data Corp.
Hematology · 57d
Cleared Sep 14, 1982
THROMBIN TIME TEST
K822466
American Dade
Hematology · 29d
Cleared Jul 16, 1981
THROMBIN CLOTTING TIME
K811109
Bio/Data Corp.
Hematology · 84d
Cleared Sep 26, 1980
FIBRI QUIK
K802117
General Diagnostics
Hematology · 22d
Cleared May 08, 1980
THROMBOQUIK THROMBIN REAGENT PROD. #3551
K800926
General Diagnostics
Hematology · 17d
Cleared Jan 10, 1979
HEPARSORB
K781781
General Diagnostics
Hematology · 83d

About Product Code GJA - Regulatory Context