K250003
- 510(k) number
- K250003
- Device name
- GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
- Applicant
- Geneseeq Technology, Inc. CA
- Product code
- PZM — Next Generation Sequencing Based Tumor Profiling Tes
- Decision date
- 2025-08-29
- Date received
- 2025-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Pathology
510(k) Summary (official FDA PDF): K250003.pdf
Official FDA record: K250003
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.