FoundationOne CDx
FDA premarket approval P170019/S045 · decided 2024-04-25
Approval details
- PMA number
- P170019
- Supplement
- S045
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FoundationOne CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2023-05-19
- Decision date
- 2024-04-25
- Days to decision
- 342 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- approval for the migration of the F1CDx from the HiSeq 4000 to NovaSeq 6000 configuration
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