Agilent Resolution ctDx FIRST
FDA premarket approval P210040/S001 · decided 2023-07-27
Approval details
- PMA number
- P210040
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Agilent Resolution ctDx FIRST
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Exact Sciences Corporation
- Date received
- 2023-06-27
- Decision date
- 2023-07-27
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Madision, WI
- Statement
- Approval for modifications to the Instructions for Use for the Agilent Resolution Sample Collection Kit, a component of the Agilent Resolution ctDx FIRST assay
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