# Vela Diagnostics USA, Inc.

- Location (FDA's records): Fairfield, NJ
- FDA decisions: 1 (2018–2018): 1 510(k) clearance
- Product codes: OQO (1)
- Predicates its devices cite: 1 (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
- Intelligent Medical Devices, Inc.: 1 (https://510kreport.com/company/intelligent-medical-devices)

## Recent decisions
- K172509: Sentosa SA201 HSV 1/2 Qualitative PCR Test (Feb 1, 2018)

Source page: https://510kreport.com/company/vela-diagnostics-usa