PMA P230001S004
- Device
- ColoSense®
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S004
- Product code
- SBB
- Decision date
- 2024-09-06
- Classification
- Pathology
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Approval order statement
- approval of the protocol for the post-approval study (PAS).
Current openFDA PMA Record#
- Device
- ColoSense®
- Applicant
- Geneoscopy, Inc.
- PMA number
- P230001
- Supplement
- S004
- Product code
- SBB
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Decision date
- 2024-09-06
- Decision code
- APPR
- Date received
- 2024-08-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- approval of the protocol for the post-approval study (PAS).