FoundationOne Liquid CDx
FDA premarket approval P190032/S003 · decided 2022-05-25
Approval details
- PMA number
- P190032
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FoundationOne Liquid CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2021-10-28
- Decision date
- 2022-05-25
- Days to decision
- 209 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for updating of Dual Index Barcode (DIB) primer from DIBv1 to DIBv2 for F1L CDx Device.
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