# DAS: Igg (Fc Fragment Specific), Antigen, Antiserum, Control

- Device class: 1; regulation: 21 CFR 866.5530; FDA's rule: 510(k) exempt
- FDA decisions: 8
- 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)
- 1976: 1
- 1979: 2
- 1989: 1
- 1994: 3
- 1998: 1

## Most-cited predicates
- K982023: Pelicalss Human Igg Subclass Nephlometric Array Kit (1998), cited by 1

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