# NTW: System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

- Device class: 2; regulation: 21 CFR 866.4070; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 2005: 1
- 2009: 1

## Most-cited predicates
- DEN050003: Paxgene Blood Rna System (2005), cited by 2
- K082150: Modification to Paxgene Blood Rna System (2009), cited by 1

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