# JSI: Culture Media, Selective And Differential

- Device class: 1; regulation: 21 CFR 866.2360; FDA's rule: 510(k) exempt
- FDA decisions: 285
- Recalls: 7 (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: 30
- 1983: 28
- 1984: 39
- 1985: 35
- 1986: 17
- 1987: 40
- 1988: 11
- 1989: 2
- 1998: 1
- 2007: 1

## Most-cited predicates
- K881577: Modified Selective Streptococcus Agar (1988), cited by 1

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