- Device
- FoundationOne CDx (F1CDx)
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S028
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2021-11-18
- Decision code
- APPR
- Date received
- 2021-03-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of baitset update from the current DX1 baitset to a modified DX2 baitset for the F1CDx assay.