# JIH: Flame Photometry, Lithium

- Device class: 2; regulation: 21 CFR 862.3560; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 1977: 2
- 1980: 1
- 1983: 1
- 1989: 2
- 1992: 1
- 1993: 1
- 1994: 1
- 2001: 1
- 2003: 1
- 2005: 1

## Most-cited predicates
- K011033: Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132 (2001), cited by 2
- K934106: Kodak Ektachem DTSC II Slides (LI) (1994), cited by 1
- K924488: Kodak Ektachem Clinical Chemistry Slides (LI) (1993), cited by 1

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