# Promega Corporation

- Location (FDA's records): Madison
- FDA decisions: 3 (2021–2026): 1 510(k) clearance and 2 original PMA approvals
- Product codes: SFL (2), PZJ (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (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
- Ventana Medical Systems, Inc.: 1 (https://510kreport.com/company/ventana-medical-systems)

## Firms that cite its devices most
- Biocartis NV: 1 (https://510kreport.com/company/biocartis)

## Its most-cited devices
- K200129: OncoMate MSI Dx Analysis System (2021), cited by 1

## Recent decisions
- P250046: OncoMate® MSI Dx Analysis System (Sep 15, 2026)
- P240026: OncoMate® MSI Dx Analysis System (Nov 5, 2025)
- K200129: OncoMate MSI Dx Analysis System (Jul 26, 2021)

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