PMA P240010S005

Device: MI Cancer Seek
Applicant: Caris Life Sciences
PMA number: P240010
Supplement: S005
Product code: PQP
Decision date: 2025-06-18
Classification: Medical Genetics
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: approval for changes to the equipment validation acceptance criteria for the qualification of serial number-controlled instruments

Current openFDA PMA Record#

Device: MI Cancer Seek
Applicant: Caris Life Sciences
PMA number: P240010
Supplement: S005
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2025-06-18
Decision code: OK30
Date received: 2025-05-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for changes to the equipment validation acceptance criteria for the qualification of serial number-controlled instruments