# Cd Diagnostics, Inc.

- Location (FDA's records): Claymont, DE
- FDA decisions: 2 (2019–2021): 1 510(k) clearance and 1 De Novo grant
- Product codes: QGN (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
- Lumos Diagnostics, Inc.: 1 (https://510kreport.com/company/lumos-diagnostics)

## Its most-cited devices
- DEN180032: Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit (2019), cited by 2

## Recent decisions
- K212204: Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit (Aug 11, 2021)
- DEN180032: Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit (May 23, 2019)

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