PMA P210011S002

Device: xT CDx
Applicant: Tempus AI, Inc.
PMA number: P210011
Supplement: S002
Product code: PQP
Decision date: 2026-09-02
Classification: Pathology
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval for a Pre-specified Change Control Plan (PCCP) to modify the use of the device at a single laboratory to multiple laboratories

Current openFDA PMA Record#

Device: xT CDx
Applicant: Tempus AI, Inc.
PMA number: P210011
Supplement: S002
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2026-09-02
Decision code: APPR
Date received: 2025-02-07
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a Pre-specified Change Control Plan (PCCP) to modify the use of the device at a single laboratory to multiple laboratories