# MJH: Legionella, Spp., Elisa

- Device class: 2; regulation: 21 CFR 866.3300; FDA's rule: 510(k) exempt
- FDA decisions: 10
- Recalls: 2 (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)
- 1992: 1
- 1994: 1
- 1998: 1
- 1999: 1
- 2003: 1
- 2007: 2
- 2012: 1
- 2017: 1
- 2020: 1

## Most-cited predicates
- K982238: Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522 (1998), cited by 3
- K934965: Binax Legionella Urinary Antigen Eia (1994), cited by 1
- K070522: Modification to: Binax Now  Legionella Urinary Antigen Test, #852-000,852-012 (2007), cited by 1

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