PMA P230001S009
- Device
- ColoSense®
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S009
- Product code
- SBB
- Decision date
- 2025-09-15
- Classification
- Pathology
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Approval order statement
- Submission is approved.
Current openFDA PMA Record#
- Device
- ColoSense®
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S009
- Product code
- SBB
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Decision date
- 2025-09-15
- Decision code
- APPR
- Date received
- 2025-07-16
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Submission is approved.