# GMZ: Antigens, All Types, Escherichia Coli

- Device class: 1; regulation: 21 CFR 866.3255; FDA's rule: 510(k) exempt
- FDA decisions: 14
- 510(k) review time 2021–2025: median 210 days (middle half 210–210)
- 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)
- 1994: 1
- 1995: 1
- 1997: 2
- 1998: 2
- 1999: 1
- 2003: 1
- 2006: 1
- 2007: 1
- 2012: 2
- 2023: 1

## Most-cited predicates
- K980507: Prospect Shiga Toxin Microplate Assay (1998), cited by 3
- K062546: Immunocard Stat! Ehec, Model 751630 (2007), cited by 2
- K121364: Shiga Toxin Quik Chek (2012), cited by 1
- K061889: Biostar Oia Shigatox (2006), cited by 1

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