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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 the device name listed in this FDA 510(k) record. The listed applicant is Geneseeq Technology, Inc.. It received FDA 510(k) clearance on 2025-08-29 under 510(k) 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. The listed applicant is Geneseeq Technology, Inc.. The 510(k) number is K250003.

When did GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) receive FDA 510(k) clearance?

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

Who is the listed applicant for GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)?

The FDA 510(k) record lists Geneseeq Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: PZM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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