FDA 510(k)

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)

Номер K: K250003 · 2025-08-29

Дата решения2025-08-29

Код продуктаPZM

Консультативный комитетPA

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: PZM)

K260235CellDx-TissueDatar Cancer Genetics Private Limited K241868xR IVDTempus AI, Inc.K210017ACTOnco, ACTOnco IVDAct Genomics K202304NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)Nyu Langone Medical Center K192063PGDx elio tissue completePersonal Genome Diagnostics K190661Omics CoreNanthealth, Inc.

Официальный источник

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