# Healgen

- Location (FDA's records): Houston, TX
- FDA decisions: 1 (2024–2024): 1 De Novo grant
- Product codes: SCA (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 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
- Nano-Ditech Corporation: 1 (https://510kreport.com/company/nano-ditech)
- Osang, LLC: 1 (https://510kreport.com/company/osang)
- Princeton BioMeditech Corp.: 1 (https://510kreport.com/company/princeton-biomeditech)
- Wondfo USA Co, Ltd.: 1 (https://510kreport.com/company/wondfo-usa)

## Its most-cited devices
- DEN240029: Healgen Rapid Check COVID-19/Flu A&B Antigen Test (2024), cited by 4

## Recent decisions
- DEN240029: Healgen Rapid Check COVID-19/Flu A&B Antigen Test (Oct 7, 2024)

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