PMA P240010S002
- Device
- MI Cancer Seek
- Applicant
- Caris Life Sciences
- PMA number
- P240010
- Supplement
- S002
- Product code
- PQP
- Decision date
- 2025-01-07
- Classification
- Medical Genetics
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- in-process quality control specification changes for components of the MI Cancer Seek assay
Current openFDA PMA Record#
- Device
- MI Cancer Seek
- Applicant
- Caris Life Sciences
- PMA number
- P240010
- Supplement
- S002
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2025-01-07
- Decision code
- OK30
- Date received
- 2024-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- in-process quality control specification changes for components of the MI Cancer Seek assay