PMA P200010S013

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
Product code: PQP
Decision date: 2023-05-08
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval for sourcing one of the Sample Preparation Kit reagents, which is used in Guardant360 CDx assay from a new vendor.

Current openFDA PMA Record

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S013
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2023-05-08
Decision code: APPR
Date received: 2023-03-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for sourcing one of the Sample Preparation Kit reagents, which is used in Guardant360 CDx assay from a new vendor.