DDQ · Class II · 21 CFR 864.7060

FDA Product Code DDQ: Antigen, Antiserum, Control, Antithrombin Iii

Leading manufacturers include Ria Diagnostics, Trace Scientific , Ltd. and Baxter Diagnostics, Inc..

4
Total
4
Cleared
161d
Avg days
1978
Since

FDA 510(k) Cleared Antigen, Antiserum, Control, Antithrombin Iii Devices (Product Code DDQ)

4 devices
1–4 of 4
Cleared Oct 20, 1997
N-ASSAY TIA ANTITHROMBIN III TEST KIT
K972257
Crestat Diagnostics, Inc.
Hematology · 125d
Cleared Nov 22, 1994
DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA
K935307
Baxter Diagnostics, Inc.
Hematology · 385d
Cleared Sep 30, 1993
TRACE TRANSFERRIN REAGENT
K932713
Trace Scientific , Ltd.
Hematology · 118d
Cleared Jan 20, 1978
ANTITHROMBIN III RIA
K780012
Ria Diagnostics
Hematology · 17d

About Product Code DDQ - Regulatory Context