DDC — Thyroglobulin, Antigen, Antiserum, Control Class II
FDA product code DDC covers "Thyroglobulin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5870. Submissions are reviewed by the Immunology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DDC
- Device Class
- Class II
- Regulation Number
- 866.5870
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K023592 | quest intl | SERAQUEST ANTI-THYROGLOBULIN | January 6, 2003 |
| K012208 | beckman coulter | ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, | September 7, 2001 |
| K000363 | zeus scientific | MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | February 18, 2000 |
| K991610 | zeus scientific | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. | June 25, 1999 |
| K991179 | zeus scientific | ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | June 17, 1999 |
| K971835 | monobind | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA | July 3, 1997 |
| K953066 | fujirebio america | SERODIA ATG | August 14, 1995 |
| K943625 | cogent diagnotics | AUTOSTAT II ANTI-THYROGLOBULIN | December 22, 1994 |
| K936010 | biomerica | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY | July 18, 1994 |
| K930486 | inova diagnostics | QUANTA LITE(TM) THYROID T ELISA | March 15, 1993 |
| K865020 | miles laboratories | SERA-TEK THYROGLOBULIN ANTIBODY TEST | February 2, 1987 |
| K780873 | burroughs wellcome | THYMUNE-M | June 14, 1978 |
| K780874 | burroughs wellcome | THYMUNE-T | June 14, 1978 |