# NOM: Antigen, Galactomannan, Aspergillus Spp.

- Device class: 1; regulation: 21 CFR 866.3040; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 262 days (middle half 262–262)
- 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)
- 2003: 1
- 2006: 1
- 2011: 1
- 2025: 1

## Most-cited predicates
- K060641: Platelia Aspergillus Eia, Model 62793 (2006), cited by 2
- K093678: Platelia Aspergillus Eia Model 62793 (2011), cited by 1
- K023857: Platelia Aspergillus Eia, Models 62793 and 62794 (2003), cited by 1

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