PMA P230001S001
- Device
- ColoSense
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S001
- Product code
- SBB
- Decision date
- 2024-08-23
- Classification
- Pathology
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Approval order statement
- Approval to use a different blocking reagent.
Current openFDA PMA Record#
- Device
- ColoSense
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S001
- Product code
- SBB
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Decision date
- 2024-08-23
- Decision code
- APPR
- Date received
- 2024-05-24
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to use a different blocking reagent.