# GJR: Control, Red-Cell

- Device class: 2; regulation: 21 CFR 864.8625; 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)
- 1990: 1
- 1995: 1
- 2000: 1
- 2006: 1
- 2008: 1

## Most-cited predicates
- K000076: Cell-Chex (2000), cited by 3
- K940430: Sedratrol (1995), cited by 2
- K060083: NRBC-Chex for LH (2006), cited by 1
- K900484: Ret-Check (1990), cited by 1

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