ColoSense
FDA premarket approval P230001/S007 · decided 2024-12-19
Approval details
- PMA number
- P230001
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ColoSense
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Applicant
- Geneoscopy, Inc.
- Date received
- 2024-11-25
- Decision date
- 2024-12-19
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- SBB
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- St. Louis, MO
- Statement
- approval to add an alternative supplier of a device component
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