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510(k) Data Aggregation

K Number

Device Name

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)

Manufacturer

Geneseeq Technology Inc.

Date Cleared

2025-08-29

(239 days)

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Panel

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N/A

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Device Name :

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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