- Device
- ColoSense®
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S011
- Product code
- SBB
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Decision date
- 2025-10-24
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for modifying the concentration of a reagent used in the manufacturing process of QC materials and the qualification of an alternate reagent supplier