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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Next Generation Sequencing Based Tumor Profiling Test
510(k) Number K250003
Device Name GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
Applicant
Geneseeq Technology, Inc.
Suite 1802, 393 University Ave.
Toronto,  CA M5G 1E6
Applicant Contact Xue Wu
Correspondent
Geneseeq Technology, Inc.
Suite 1802, 393 University Ave.
Toronto,  CA M5G 1E6
Correspondent Contact Xue Wu
Regulation Number866.6080
Classification Product Code
PZM  
Date Received01/02/2025
Decision Date 08/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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