PMA P230001S002
- Device
- ColoSense
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S002
- Product code
- SBB
- Decision date
- 2024-08-08
- Classification
- Pathology
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Approval order statement
- Approval to add a new label to the Colosense Collection Kit outer box
Current openFDA PMA Record#
- Device
- ColoSense
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S002
- Product code
- SBB
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Decision date
- 2024-08-08
- Decision code
- OK30
- Date received
- 2024-07-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add a new label to the Colosense Collection Kit outer box