# JIF: Enzymatic Method, Ammonia

- Device class: 1; regulation: 21 CFR 862.1065; FDA's rule: 510(k) required
- FDA decisions: 30
- Recalls: 3 (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)
- 1998: 3
- 1999: 1
- 2000: 2
- 2002: 2
- 2003: 1
- 2004: 1
- 2005: 1
- 2006: 1
- 2013: 2
- 2019: 1

## Most-cited predicates
- K770363: Aca Ammonia Analytical Test Pack (1977), cited by 2
- K760332: Sigma Ammonia Reagent (1976), cited by 1
- K974620: Ammonia-Incorporating Dynamic Stabilization Technology (DST) (1998), cited by 1
- K003196: Synchron Systems Ammonia Reagent (2000), cited by 1
- K913124: Roche Reagent for Ammonia (1991), cited by 1
- K870787: Abbott Spectrum Ammonia Reagent (1987), cited by 1

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