FoundationOne Liquid CDx (F1 Liquid CDx)
FDA premarket approval P200006/S004 · decided 2023-03-08
Approval details
- PMA number
- P200006
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- FoundationOne Liquid CDx (F1 Liquid CDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2022-09-09
- Decision date
- 2023-03-08
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval for Waiver of Condition of Approval (CoA) for Contrived Sample Functional Characterization (CSFC) study for F1 Liquid CDx.
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