ColoSense®
FDA premarket approval P230001/S010 · decided 2025-08-14
Approval details
- PMA number
- P230001
- Supplement
- S010
- 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
- 2025-07-22
- Decision date
- 2025-08-14
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- SBB
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- St. Louis, MO
- Statement
- approval to modify the volume of specific kit reagents during the manufacturing process
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.