# DDB: Ceruloplasmin, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5210; FDA's rule: 510(k) exempt
- FDA decisions: 19
- Recalls: 0 (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)
- 1981: 1
- 1982: 1
- 1985: 3
- 1986: 1
- 1989: 1
- 1991: 1
- 1997: 1
- 2006: 1
- 2013: 1
- 2017: 1

## Most-cited predicates
- K791339: Human Ceruloplasmin (1979), cited by 2
- K053074: N Antisera to Human Ceruloplasmin (2006), cited by 2
- K812486: Immunogl. FRCT. of Rabbit Antiser.-Cerul (1981), cited by 1

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