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
K936010 BIOMERICA, INC. THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY 07/18/1994
K780873 BURROUGHS WELLCOME CO. THYMUNE-M 06/14/1978
K780874 BURROUGHS WELLCOME CO. THYMUNE-T 06/14/1978
K943625 COGENT DIAGNOTICS LTD. AUTOSTAT II ANTI-THYROGLOBULIN 12/22/1994
K953066 FUJIREBIO AMERICA, INC. SERODIA ATG 08/14/1995
K930486 INOVA DIAGNOSTICS, INC. QUANTA LITE(TM) THYROID T ELISA 03/15/1993
K865020 MILES LABORATORIES, INC. SERA-TEK THYROGLOBULIN ANTIBODY TEST 02/02/1987
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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