DDC · Class II · 21 CFR 866.5870

FDA Product Code DDC: Thyroglobulin, Antigen, Antiserum, Control

Leading manufacturers include Zeus Scientific, Inc., Burroughs Wellcome Co. and Cogent Diagnotics , Ltd..

13
Total
13
Cleared
64d
Avg days
1978
Since

FDA 510(k) Cleared Thyroglobulin, Antigen, Antiserum, Control Devices (Product Code DDC)

13 devices
1–13 of 13
Cleared Jan 06, 2003
SERAQUEST ANTI-THYROGLOBULIN
K023592
Quest Intl., Inc.
Immunology · 73d
Cleared Sep 07, 2001
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
K012208
Beckman Coulter, Inc.
Immunology · 53d
Cleared Feb 18, 2000
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
K000363
Zeus Scientific, Inc.
Immunology · 14d
Cleared Jun 25, 1999
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
K991610
Zeus Scientific, Inc.
Immunology · 46d
Cleared Jun 17, 1999
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
K991179
Zeus Scientific, Inc.
Immunology · 71d
Cleared Jul 03, 1997
ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
K971835
Monobind
Immunology · 45d
Cleared Dec 22, 1994
AUTOSTAT II ANTI-THYROGLOBULIN
K943625
Cogent Diagnotics , Ltd.
Immunology · 149d
Cleared Mar 15, 1993
QUANTA LITE(TM) THYROID T ELISA
K930486
Inova Diagnostics, Inc.
Immunology · 45d
Cleared Feb 02, 1987
SERA-TEK THYROGLOBULIN ANTIBODY TEST
K865020
Miles Laboratories, Inc.
Immunology · 41d
Cleared Jun 14, 1978
THYMUNE-M
K780873
Burroughs Wellcome Co.
Immunology · 15d
Cleared Jun 14, 1978
THYMUNE-T
K780874
Burroughs Wellcome Co.
Immunology · 15d

About Product Code DDC - Regulatory Context