PMA P240010S001

Device: MI Cancer Seek
Applicant: Caris Life Sciences
PMA number: P240010
Supplement: S001
Product code: PQP
Decision date: 2025-02-06
Classification: Medical Genetics
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order 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.

Current openFDA PMA Record#

Device: MI Cancer Seek
Applicant: Caris Life Sciences
PMA number: P240010
Supplement: S001
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2025-02-06
Decision code: APPR
Date received: 2024-11-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.