# Primeradx

- Location (FDA's records): Mansfield, MA
- FDA decisions: 1 (2013–2013): 1 510(k) clearance
- Product codes: OZN (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
- Geneohm Sciences Canada, Inc. (Bd Diagnostics): 1 (https://510kreport.com/company/geneohm-sciences-canada-bd-diagnostics)

## Recent decisions
- K132726: Iceplex C. Difficile Assay Kit, Iceplex System (Nov 29, 2013)

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