# Quest Diagnostics Nichols Institute

- Location (FDA's records): San Juan Capistrano
- FDA decisions: 1 (2025–2025): 1 original PMA approval
- Product codes: QWQ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- P250002: Quest Diagnostics AAVrh74 Antibody ELISA CDx (Jul 24, 2025)

Source page: https://510kreport.com/company/quest-diagnostics-nichols-institute