MI Cancer Seek
FDA premarket approval P240010/S002 · decided 2025-01-07
Approval details
- PMA number
- P240010
- Supplement
- S002
- 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
- 2024-12-19
- Decision date
- 2025-01-07
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- PQP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Phoenix, AZ
- Statement
- in-process quality control specification changes for components of the MI Cancer Seek assay
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