# Biocartis NV

- Location (FDA's records): Mechelen, BE
- FDA decisions: 1 (2023–2023): 1 510(k) clearance
- Product codes: PZJ (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
- Promega Corporation: 1 (https://510kreport.com/company/promega)

## Recent decisions
- K211181: Idylla MSI Test (Feb 27, 2023)

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