MI Cancer Seek
FDA premarket approval P240010/S003 · decided 2025-06-04
Approval details
- PMA number
- P240010
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MI Cancer Seek
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Caris Life Sciences
- Date received
- 2025-03-05
- Decision date
- 2025-06-04
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Phoenix, AZ
- Statement
- Approval for protocols to establish reagent shelf-life and in-use/open kit stability claims.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.