GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)— 510(k) K250003

Name: FDA 510(k) clearance K250003
Creator: U.S. Food and Drug Administration
Published: 2025-08-29

Substantially Equivalent

Geneseeq Technology, Inc.

FDA 510(k) clearance K250003 for GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005), Substantially Equivalent on 2025-08-29. Applicant: Geneseeq Technology, Inc.. Device class: 2.

Clearance details

Applicant: Geneseeq Technology, Inc.
Product code: Code PZM
Device class: Class 2
Regulation: 21 CFR 866.6080
Advisory panel: Pathology
Date received: 2025-01-02
Decision date: 2025-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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