FoundationOne Liquid CDx (F1CDx)
FDA premarket approval P190032/S024 · decided 2024-12-12
Approval details
- PMA number
- P190032
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne Liquid CDx (F1CDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2024-06-17
- Decision date
- 2024-12-12
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- approval for updates to the FoundationOne Liquid CDx (F1LCDx) labeling documents.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.