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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