GJA · Class II · 21 CFR 864.7875

FDA Product Code GJA: Test, Thrombin Time

Leading manufacturers include American Bioproducts Co., Behring Diagnostics, Inc. and American Dade.

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 May 14, 1993
TEST THROMBIN
K930157
Behring Diagnostics, Inc.
Hematology · 121d
Cleared May 01, 1992
THROMBIN CLOTTING TIME REAGENT
K920147
Helena Laboratories
Hematology · 109d
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 Sep 14, 1982
THROMBIN TIME TEST
K822466
American Dade
Hematology · 29d

About Product Code GJA - Regulatory Context