# Foundation Medicine, Inc.

- Location (FDA's records): Cambridge
- FDA decisions: 5 (2016–2020): 5 original PMA approvals
- Product codes: PQP (5)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- P200016: FoundationOne Liquid CDx (Nov 6, 2020)
- P200006: FoundationOne Liquid CDx (F1 Liquid CDx) (Oct 26, 2020)
- P190032: FoundationOne Liquid CDx (F1 Liquid CDx) (Aug 26, 2020)
- P170019: FoundationOne CDx (Nov 30, 2017)
- P160018: FoundationFocus CDxBRCA (Dec 19, 2016)

Source page: https://510kreport.com/company/foundation-medicine