PMA P170019S018
- Device
- FoundationOne CDx (F1CDx)
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S018
- Product code
- PQP
- Decision date
- 2020-05-13
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Re-execution of the Test Method Validation.
Current openFDA PMA Record#
- Device
- FoundationOne CDx (F1CDx)
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S018
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2020-05-13
- Decision code
- OK30
- Date received
- 2020-04-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Re-execution of the Test Method Validation.