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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 a medical device manufactured by Nyu Langone Medical Center. It received FDA 510(k) clearance on 2021-07-14 under approval 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. It is manufactured by Nyu Langone Medical Center. The 510(k) number is K202304.

When was NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) approved by the FDA?

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

What company makes NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)?

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) is manufactured by Nyu Langone Medical Center.

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.

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Related PubMed Literature

PMID: 40355427 Comprehensive molecular profiling of FH-deficient renal cell carcinoma identifies molecular subtypes and potential therapeutic targets. Nature communications (2025)

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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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