# Nuclein, LLC

- Location (FDA's records): Austin, TX
- FDA decisions: 2 (2024–2026): 2 510(k) clearances
- Product codes: QOF (1), OCC (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biofire Diagnostics, LLC: 1 (https://510kreport.com/company/biofire-diagnostics)

## Recent decisions
- K261347: DASH Flu A/B Test (Oct 21, 2026)
- K241652: DASH® SARS-CoV-2 & Flu A/B Test (Dec 20, 2024)

Source page: https://510kreport.com/company/nuclein