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FDA 510(k)

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

K-Number: K202304 · 2021-07-14

ApplicantNyu Langone Medical Center
Decision Date2021-07-14
Product CodePZM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

K260235CellDx-TissueDatar Cancer Genetics Private LimitedK241868xR IVDTempus AI, Inc.K250003GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc.K210017ACTOnco, ACTOnco IVDAct GenomicsK192063PGDx elio tissue completePersonal Genome DiagnosticsK190661Omics CoreNanthealth, Inc.

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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