# NYO: Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

- Device class: 2; regulation: 21 CFR 866.5100; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 376 days (middle half 376–376)
- 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)
- 2006: 1
- 2007: 1
- 2018: 1
- 2021: 1

## Most-cited predicates
- K202541: EliA RNA Pol III (2021), cited by 1
- K070066: Quanta Lite Rna Pol Iii Elisa (2007), cited by 1

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