PMA P240010
- Device
- MI Cancer Seek
- Applicant
- Caris Life Sciences
- Product code
- PQP
- Decision date
- 2026-07-02
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- update to QC specification limits
Current openFDA PMA Record#
- Device
- MI Cancer Seek
- Applicant
- Caris Life Sciences
- PMA number
- P240010
- Supplement
- S010
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2026-07-02
- Decision code
- OK30
- Date received
- 2026-06-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- update to QC specification limits