ColoSense®
FDA premarket approval P230001/S011 · decided 2025-10-24
Approval details
- PMA number
- P230001
- Supplement
- S011
- 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
- 2025-09-30
- Decision date
- 2025-10-24
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- SBB
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- St. Louis, MO
- Statement
- approval for modifying the concentration of a reagent used in the manufacturing process of QC materials and the qualification of an alternate reagent supplier
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