# JPE: Antithrombin Iii, Two Stage Clotting Time Assay

- Device class: 2; regulation: 21 CFR 864.7060; FDA's rule: 510(k) required
- FDA decisions: 1
- 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)
- 1994: 1

## Most-cited predicates
- K933125: Berichrom Antithrombin Iii (a) (1994), cited by 3

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