PMA P200010S005

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S005
Product code: PQP
Decision date: 2022-03-16
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval to use reagent lots interchangeably for Guardant360 CDx Sample Preparation Kit Boxes and a minor software update to accommodate the reagent interchangeability update.

Current openFDA PMA Record#

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S005
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2022-03-16
Decision code: APPR
Date received: 2021-12-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to use reagent lots interchangeably for Guardant360 CDx Sample Preparation Kit Boxes and a minor software update to accommodate the reagent interchangeability update.