# JIY: Photometric Method, Iron (Non-Heme)

- Device class: 1; regulation: 21 CFR 862.1410; FDA's rule: 510(k) exempt
- FDA decisions: 67
- Recalls: 17 (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)
- 1995: 2
- 1996: 1
- 1997: 3
- 1998: 1
- 2001: 1
- 2002: 1
- 2003: 1
- 2004: 1
- 2005: 1
- 2006: 2

## Most-cited predicates
- K944911: Ace Iron Reagent (1995), cited by 2
- K864819: Raichem (TM)Serum Iron and Tibc Reagents (1987), cited by 2
- K060264: Dimension Iron Flex Reagent Cartridge (Iron-DF85) (2006), cited by 1
- K870986: Liquid-Stat Iron Reagent Kit & Tibc Reagent Kit (1987), cited by 1
- K972363: IL Test Iron (1997), cited by 1

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