Guardant360 CDx
FDA premarket approval P200010/S019 · decided 2024-06-11
Approval details
- PMA number
- P200010
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Guardant360 CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Guardant Health, Inc.
- Date received
- 2024-05-13
- Decision date
- 2024-06-11
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- to allow changing the order of QC testing for the Sample Preparation Kit (SPK)
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