# Paragondx, LLC

- Location (FDA's records): Morrisville, NC
- FDA decisions: 1 (2008–2008): 1 510(k) clearance
- Product codes: ODV (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- K071867: Rapid Genotyping Assay -CYP2C9 & VKORC1, Model Catalog NO. 006+0203 Gactga (Apr 28, 2008)

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