# Cue Health, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 2 (2023–2023): 1 510(k) clearance and 1 De Novo grant
- Product codes: QWB (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Visby Medical, Inc.: 1 (https://510kreport.com/company/visby-medical)
- Aptitude Medical Systems, Inc.: 1 (https://510kreport.com/company/aptitude-medical-systems)

## Its most-cited devices
- DEN220028: Cue COVID-19 Molecular Test (2023), cited by 3

## Recent decisions
- K232643: Cue COVID-19 Molecular Test (Nov 28, 2023)
- DEN220028: Cue COVID-19 Molecular Test (Jun 6, 2023)

Source page: https://510kreport.com/company/cue-health