Guardant360 CDx
FDA premarket approval P200010/S006 · decided 2022-06-27
Approval details
- PMA number
- P200010
- Supplement
- S006
- 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
- 2021-12-23
- Decision date
- 2022-06-27
- Days to decision
- 186 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for upgrading Guardant360 CDx software sub-component Bioinformatics Pipeline (BIP) software from v3.5.3 to v3.5.4.
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