DDC · Class II · 21 CFR 866.5870

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

Leading manufacturers include Zeus Scientific, Inc., Beckman Coulter, Inc. and Miles Laboratories, Inc..

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 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 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

About Product Code DDC - Regulatory Context