FoundationOne CDx (F1CDx)
FDA premarket approval P170019/S063 · decided 2024-12-18
Approval details
- PMA number
- P170019
- Supplement
- S063
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FoundationOne CDx (F1CDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2024-11-22
- Decision date
- 2024-12-18
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- a change in the manufacturing workflow of a material used in F1CDx and F1LCDx assays
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