FDA 510(k) Applications for Medical Device Product Code "DDC"
(Thyroglobulin, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K012208 BECKMAN COULTER, INC. ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 09/07/2001
K971835 MONOBIND ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA 07/03/1997
K023592 QUEST INTL., INC. SERAQUEST ANTI-THYROGLOBULIN 01/06/2003
K000363 ZEUS SCIENTIFIC, INC. MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM 02/18/2000
K991610 ZEUS SCIENTIFIC, INC. ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. 06/25/1999
K991179 ZEUS SCIENTIFIC, INC. ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM 06/17/1999


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