GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
FDA 510(k) clearance K250003 · decided 2025-08-29
Clearance details
- K-number
- K250003
- Device name
- GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
- Applicant
- Geneseeq Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-02
- Decision date
- 2025-08-29
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- PZM
- Device class
- 2
- Regulation number
- 866.6080
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Omics Core (K190661) | Nanthealth, Inc. | 2019-11-09 |
| MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay (DEN170058) | Memorial Sloan-Kettering Cancer Center | 2017-11-15 |
Recalls involving this device
No recalls on record reference this clearance.