# JJR: Electrolyte Controls (Assayed And Unassayed)

- Device class: 1; regulation: 21 CFR 862.1660; FDA's rule: 510(k) exempt
- FDA decisions: 17
- 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)
- 1986: 1
- 1988: 3
- 1989: 2
- 1990: 1
- 1991: 1
- 1993: 1
- 1994: 1
- 1995: 1
- 1996: 2
- 1999: 1

## Most-cited predicates
- K881773: Document (TM) Direct Ise Linearity Test Set (1988), cited by 3
- K955630: Rna Medical Hemat Control (1996), cited by 3
- K934641: I-Stat Control  Levels 1,2,3 (1993), cited by 2

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