# GIT: Reagent & Control, Partial Thromboplastin Time

- Device class: 2; regulation: 21 CFR 864.7925; FDA's rule: 510(k) required
- FDA decisions: 4
- 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)
- 1982: 1
- 1988: 2
- 1989: 1

## Most-cited predicates
- K820450: Thromboscreen (1982), cited by 1
- K890051: Biotrack Aptt Controls (1989), cited by 1

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