# DFZ: Igg (Gamma Chain Specific), Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5510; FDA's rule: 510(k) required
- FDA decisions: 9
- 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)
- 1979: 2
- 1981: 2
- 1994: 1
- 1996: 1
- 2002: 2
- 2009: 1

## Most-cited predicates
- K955906: Boehringer Mannheim Igg Assay (1996), cited by 2

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