# DDX: Plasminogen, Antigen, Antiserum, Control

- Device class: 1; regulation: 21 CFR 866.5715; FDA's rule: 510(k) exempt
- FDA decisions: 10
- 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)
- 1978: 2
- 1981: 2
- 1983: 1
- 1985: 1
- 1986: 2
- 1989: 1
- 1994: 1

## Most-cited predicates
- K864212: IL Test 97573-15, Plasminogen Assay (1986), cited by 1
- K854572: Coatest Plasminogen (1986), cited by 1

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