MI Cancer Seek
FDA premarket approval P240010/S001 · decided 2025-02-06
Approval details
- PMA number
- P240010
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MI Cancer Seek
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Caris Life Sciences
- Date received
- 2024-11-08
- Decision date
- 2025-02-06
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Phoenix, AZ
- Statement
- Approval for a predetermined change control plan (PCCP) that includes minor software modifications consistent with the intended use of the assay and qualification of serial number-controlled instrument changes.
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