PMA P230001S010
- Device
- ColoSense®
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S010
- Product code
- SBB
- Decision date
- 2025-08-14
- Classification
- Pathology
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Approval order statement
- approval to modify the volume of specific kit reagents during the manufacturing process
Current openFDA PMA Record#
- Device
- ColoSense®
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S010
- Product code
- SBB
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Decision date
- 2025-08-14
- Decision code
- OK30
- Date received
- 2025-07-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to modify the volume of specific kit reagents during the manufacturing process