ColoSense
FDA premarket approval P230001/S002 · decided 2024-08-08
Approval details
- PMA number
- P230001
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ColoSense
- Generic name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
- Applicant
- Geneoscopy, Inc.
- Date received
- 2024-07-11
- Decision date
- 2024-08-08
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- SBB
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- St. Louis, MO
- Statement
- Approval to add a new label to the Colosense Collection Kit outer box
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