# NBT: Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)

- Device class: 2; regulation: 21 CFR 866.5785; FDA's rule: 510(k) required
- FDA decisions: 8
- Recalls: 0 (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)
- 2000: 1
- 2001: 1
- 2004: 2
- 2005: 2
- 2006: 1
- 2007: 1

## Most-cited predicates
- K000733: Quanta Lite Asca (S. Cerevisiae) Iga Elisa (2001), cited by 2
- DEN000007: Quanta Lite Asca (S. Cerevisiae) Igg Elisa (2000), cited by 2
- K032860: Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga) (2004), cited by 1
- K032850: Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg) (2004), cited by 1

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