# Vermillion

- Location (FDA's records): Fremont, CA
- FDA decisions: 2 (2009–2016): 1 510(k) clearance and 1 De Novo grant
- Names in FDA's records: Vermillion (1); Vermillion, Inc. (1)
- Product codes: ONX (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 2 (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
- Fujirebio Diagnostics,Inc.: 1 (https://510kreport.com/company/fujirebio-diagnostics)

## Its most-cited devices
- DEN090004: OVA1 Test (2009), cited by 2

## Recent decisions
- K150588: OVA1 Next Generation (Mar 18, 2016)
- DEN090004: OVA1 Test (Sep 11, 2009)

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