FoundationOne Liquid CDx (F1 Liquid CDx)
FDA premarket approval P200006/S003 · decided 2022-10-28
Approval details
- PMA number
- P200006
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- 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
- 2022-09-30
- Decision date
- 2022-10-28
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval for the termination of the post-approval study (PAS) protocol.
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