FDA 510(k)

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)

Номер K: K202304 · 2021-07-14

Дата решения2021-07-14

Код продуктаPZM

Консультативный комитетPA

РешениеSubstantially Equivalent

Описание устройства

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) is the device name listed in this FDA 510(k) record. The listed applicant is Nyu Langone Medical Center. It received FDA 510(k) clearance on 2021-07-14 under 510(k) number K202304. 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 NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)?

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) is a medical device that received FDA 510(k) clearance on 2021-07-14. The listed applicant is Nyu Langone Medical Center. The 510(k) number is K202304.

When did NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) receive FDA 510(k) clearance?

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) received FDA 510(k) clearance on 2021-07-14, under 510(k) number K202304.

Who is the listed applicant for NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)?

The FDA 510(k) record lists Nyu Langone Medical Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)?

The FDA product code for NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) 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.K250003GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc.K210017ACTOnco, ACTOnco IVDAct Genomics K192063PGDx elio tissue completePersonal Genome Diagnostics K190661Omics CoreNanthealth, Inc.

Официальный источник

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