# JGJ: Photometric Method, Magnesium

- Device class: 1; regulation: 21 CFR 862.1495; FDA's rule: 510(k) required
- FDA decisions: 90
- Recalls: 11 (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)
- 1999: 2
- 2001: 2
- 2003: 1
- 2004: 2
- 2007: 1
- 2009: 2
- 2011: 1
- 2012: 1
- 2017: 2
- 2018: 2

## Most-cited predicates
- K861386: Kodak Ektachem Clinical Chemistry Slides (MG) (1986), cited by 2
- K901758: Roche Reagent for Magnesium (1990), cited by 2
- K944407: Olympus Magnesium Reagent (1994), cited by 1
- K983416: Roche Diagnostics Magnesium Reagent, Cat# 1551353 (1998), cited by 1
- K810084: Magnesium Kit (1981), cited by 1

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