Guardant360 CDx
FDA premarket approval P200010/S016 · decided 2024-03-18
Approval details
- PMA number
- P200010
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- 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
- 2023-11-17
- Decision date
- 2024-03-18
- Days to decision
- 122 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- approval for upgrading Guardant360CDx software sub-component Bioinformatics Pipeline (BIP) software from v3.5.4 to v3.5.5
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