PMA P240010S003
- Device
- MI Cancer Seek
- Applicant
- Caris Life Sciences
- PMA number
- P240010
- Supplement
- S003
- Product code
- PQP
- Decision date
- 2025-06-04
- Classification
- Medical Genetics
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Approval for protocols to establish reagent shelf-life and in-use/open kit stability claims.
Current openFDA PMA Record#
- Device
- MI Cancer Seek
- Applicant
- Caris Life Sciences
- PMA number
- P240010
- Supplement
- S003
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2025-06-04
- Decision code
- APPR
- Date received
- 2025-03-05
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for protocols to establish reagent shelf-life and in-use/open kit stability claims.