Guardant360 CDx
FDA premarket approval P200010/S013 · decided 2023-05-08
Approval details
- PMA number
- P200010
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Guardant360 CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Guardant Health, Inc.
- Date received
- 2023-03-08
- Decision date
- 2023-05-08
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for sourcing one of the Sample Preparation Kit reagents, which is used in Guardant360 CDx assay from a new vendor.
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