FoundationOne Liquid CDx (F1LCDx)
FDA premarket approval P190032/S017 · decided 2024-08-01
Approval details
- PMA number
- P190032
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FoundationOne Liquid CDx (F1LCDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2023-12-22
- Decision date
- 2024-08-01
- Days to decision
- 223 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for updates to the Library Construction (LC) and Hybrid Capture (HC) processes within the F1LCDx assay
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