ColoSense®
FDA premarket approval P230001/S008 · decided 2025-07-03
Approval details
- PMA number
- P230001
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ColoSense®
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Applicant
- Geneoscopy, Inc.
- Date received
- 2025-01-29
- Decision date
- 2025-07-03
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- SBB
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- St. Louis, MO
- Statement
- approval for a change in the contract packaging site location for the ColoSense Collection Kit
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