# DBA: Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5250; FDA's rule: 510(k) required
- FDA decisions: 13
- 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)
- 1982: 1
- 1987: 1
- 1992: 1
- 1995: 1
- 1996: 1
- 1997: 1
- 2001: 2
- 2007: 1
- 2013: 1
- 2014: 1

## Most-cited predicates
- K960257: N Antiserum to C1 Inhibitor (1996), cited by 1

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