# Omnyx, LLC

- Location (FDA's records): Marlborough, MA
- FDA decisions: 1 (2014–2014): 1 510(k) clearance
- Product codes: OEO (1)
- Predicates its devices cite: 2 (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

## Firms whose devices it cites most
- Aperio Technologies: 1 (https://510kreport.com/company/aperio-technologies)
- Ventana Medical Systems, Inc.: 1 (https://510kreport.com/company/ventana-medical-systems)

## Recent decisions
- K131140: Omnyx Idp for HER2 Manual Application (Apr 1, 2014)

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