# JSE: Culture Media, Multiple Biochemical Test

- Device class: 1; regulation: 21 CFR 866.2320; FDA's rule: 510(k) exempt
- FDA decisions: 53
- 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)
- 1980: 1
- 1981: 3
- 1982: 7
- 1983: 7
- 1984: 4
- 1985: 6
- 1986: 6
- 1987: 3
- 1988: 4
- 1996: 1

## Most-cited predicates
- K962265: MLX Microtiter Plate Luminometer (1996), cited by 1

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