PMA P190032
- Device
- FoundationOne Liquid CDx (F1 Liquid CDx)
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P190032
- Supplement
- S008
- Product code
- PQP
- Decision date
- 2026-08-12
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- approval for a change in the reagent manufacturing QC workflow
Current openFDA PMA Record#
- Device
- FoundationOne Liquid CDx (F1 Liquid CDx)
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P190032
- Supplement
- S030
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2026-08-12
- Decision code
- APPR
- Date received
- 2025-01-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a change in the reagent manufacturing QC workflow