PMA P170019S002
- Device
- FoundationOne CDx
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S002
- Product code
- PQP
- Decision date
- 2018-12-18
- Classification
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Approval for implementation of FoundationOne CDx (F1CDx) QSR pipeline v3.1.0.
Current openFDA PMA Record#
- Device
- FoundationOne CDx
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S002
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2018-12-18
- Decision code
- APPR
- Date received
- 2018-08-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for implementation of FoundationOne CDx (F1CDx) QSR pipeline v3.1.0.