PMA P230001S007
- Device
- ColoSense
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S007
- Product code
- SBB
- Decision date
- 2024-12-19
- Classification
- Pathology
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Approval order statement
- approval to add an alternative supplier of a device component
Current openFDA PMA Record#
- Device
- ColoSense
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S007
- Product code
- SBB
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Decision date
- 2024-12-19
- Decision code
- OK30
- Date received
- 2024-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to add an alternative supplier of a device component