Panels › Immunology › Product code DDC · Class 2
Thyroglobulin, Antigen, Antiserum, Control
Regulation 866.5870
0510(k)s in 12 months (13 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in DDC
| Company | 510(k)s | Recalls |
|---|---|---|
| Zeus Scientific, Inc. | 3 | 0 |
| Beckman Coulter, Inc. | 1 | 1 |
| Burroughs Wellcome Co. | 2 | 0 |
| Biomerica, Inc. | 1 | 0 |
| Cogent Diagnotics , Ltd. | 1 | 0 |
| Fujirebio America, Inc. | 1 | 0 |
| Inova Diagnostics, Inc. | 1 | 0 |
| Miles Laboratories, Inc. | 1 | 0 |
| Monobind | 1 | 0 |
| Quest Intl., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 6, 2003 | K023592 | SERAQUEST ANTI-THYROGLOBULIN Quest Intl., Inc. | DDC |
| Sep 7, 2001 | K012208 | ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 Beckman Coulter, Inc. | DDC |
| Feb 18, 2000 | K000363 | MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM Zeus Scientific, Inc. | DDC |
| Jun 25, 1999 | K991610 | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. Zeus Scientific, Inc. | DDC |
| Jun 17, 1999 | K991179 | ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM Zeus Scientific, Inc. | DDC |
| Jul 3, 1997 | K971835 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA Monobind | DDC |
| Aug 14, 1995 | K953066 | SERODIA ATG Fujirebio America, Inc. | DDC |
| Dec 22, 1994 | K943625 | AUTOSTAT II ANTI-THYROGLOBULIN Cogent Diagnotics , Ltd., GB | DDC |
| Jul 18, 1994 | K936010 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY Biomerica, Inc. | DDC |
| Mar 15, 1993 | K930486 | QUANTA LITE(TM) THYROID T ELISA Inova Diagnostics, Inc. | DDC |
| Feb 2, 1987 | K865020 | SERA-TEK THYROGLOBULIN ANTIBODY TEST Miles Laboratories, Inc. | DDC |
| Jun 14, 1978 | K780874 | THYMUNE-T Burroughs Wellcome Co. | DDC |
| Jun 14, 1978 | K780873 | THYMUNE-M Burroughs Wellcome Co. | DDC |
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