# GJA: Test, Thrombin Time

- Device class: 2; regulation: 21 CFR 864.7875; FDA's rule: 510(k) required
- FDA decisions: 20
- Recalls: 4 (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)
- 1986: 1
- 1988: 2
- 1989: 1
- 1990: 1
- 1992: 2
- 1993: 1
- 1994: 1
- 1997: 1
- 1998: 1
- 2005: 1

## Most-cited predicates
- K884384: Thrombin-Prest Reagent Kit (1988), cited by 1
- K862301: IL System 810, Acl and the Reagent Sets (1986), cited by 1
- K970645: BC Thrombin Reagent (1997), cited by 1

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