# DAK: Complement C1q, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5240; FDA's rule: 510(k) required
- FDA decisions: 28
- 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)
- 1984: 3
- 1985: 3
- 1986: 2
- 1987: 2
- 1988: 1
- 1991: 1
- 1995: 1
- 1998: 2
- 2002: 1
- 2003: 2

## Most-cited predicates
- K851202: Gilford Tri-Level Assayed Immunology Control (1985), cited by 3

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