PMA P230001S008
- Device
- ColoSense®
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S008
- Product code
- SBB
- Decision date
- 2025-07-03
- Classification
- Pathology
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Approval order statement
- approval for a change in the contract packaging site location for the ColoSense Collection Kit
Current openFDA PMA Record#
- Device
- ColoSense®
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S008
- Product code
- SBB
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Decision date
- 2025-07-03
- Decision code
- APPR
- Date received
- 2025-01-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a change in the contract packaging site location for the ColoSense Collection Kit