Clearance Summary
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) received FDA 510(k) clearance under submission number K250003, sponsored by Geneseeq Technology, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2025-08-29.
- Submission: K250003
- Applicant / Sponsor: Geneseeq Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 866.6080
- Decision date: 2025-08-29
Classification & Regulation
This clearance is catalogued under FDA product code PZM and 21 CFR 866.6080, within the Pathology review panel as a Class II device.