# JSS: Kit, Identification, Enterobacteriaceae

- Device class: 1; regulation: 21 CFR 866.2660; FDA's rule: 510(k) exempt
- FDA decisions: 49
- Recalls: 8 (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: 5
- 1988: 1
- 1989: 2
- 1992: 2
- 1993: 4
- 2008: 1
- 2009: 4
- 2010: 1
- 2013: 1
- 2015: 1

## Most-cited predicates
- K123418: Gram-Negative Quickfish BC (2013), cited by 1

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