# DEX: Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control

- Device class: 1; regulation: 21 CFR 866.5420; FDA's rule: 510(k) exempt
- FDA decisions: 5
- 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
- 1978: 1
- 1979: 1
- 1980: 1
- 1982: 1

## Most-cited predicates
- K791341: Human Alpha, Acid Glycoprotein (1979), cited by 2

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