# JJC: Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use

- Device class: 1; regulation: 21 CFR 862.2150; FDA's rule: 510(k) exempt
- FDA decisions: 32
- Recalls: 1 (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: 1
- 1983: 2
- 1985: 2
- 1986: 1
- 1987: 1
- 1988: 2
- 1989: 1
- 1990: 2
- 1994: 1
- 1995: 2

## Most-cited predicates
- K945915: Avl Omni Analyzer (1995), cited by 1

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