MI Cancer Seek
FDA premarket approval P240010/S005 · decided 2025-06-18
Approval details
- PMA number
- P240010
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MI Cancer Seek
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Caris Life Sciences
- Date received
- 2025-05-19
- Decision date
- 2025-06-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PQP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Phoenix, AZ
- Statement
- approval for changes to the equipment validation acceptance criteria for the qualification of serial number-controlled instruments
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.