# DDC: Thyroglobulin, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5870; FDA's rule: 510(k) required
- FDA decisions: 13
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1978: 2
- 1987: 1
- 1993: 1
- 1994: 2
- 1995: 1
- 1997: 1
- 1999: 2
- 2000: 1
- 2001: 1
- 2003: 1

## Most-cited predicates
- K012208: Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay Systems, Models 33890, 33895 (2001), cited by 1

Source page: https://510kreport.com/product-code/DDC
Data by year (CSV): https://510kreport.com/product-code/DDC.csv