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FDA 510(k)

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)

K-Number: K250003 · 2025-08-29

ApplicantGeneseeq Technology, Inc.
Decision Date2025-08-29
Product CodePZM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) is a medical device manufactured by Geneseeq Technology, Inc.. It received FDA 510(k) clearance on 2025-08-29 under approval number K250003. The device is classified under product code PZM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)?

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) is a medical device that received FDA 510(k) clearance on 2025-08-29. It is manufactured by Geneseeq Technology, Inc.. The 510(k) number is K250003.

When was GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) approved by the FDA?

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) received FDA 510(k) clearance on 2025-08-29, under approval number K250003.

What company makes GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)?

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) is manufactured by Geneseeq Technology, Inc..

What is the FDA product code for GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)?

The FDA product code for GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) is PZM.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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