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510(k) Data Aggregation

    K Number
    K202304
    Device Name
    NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
    Manufacturer
    NYU Langone Medical Center
    Date Cleared
    2021-07-14

    (334 days)

    Product Code
    PZM
    Regulation Number
    866.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    NYU Langone Medical Center

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NYU Langone Genome PACT assay is a qualitative in vitro diagnostic test that uses targeted next generation sequencing of formalin-fixed paraffin-embedded (FFPE) tumor tissue matched with normal specimens with solid malignant neoplasms to detect tumor gene alterations in a 607-gene panel. The test is intended to provide information on somatic mutations and small insertions and deletions) for use by qualified health care professionals in accordance with professional guidelines, and is not conclusive or prescriptive for labeled use of any specific therapeutic product. NYU Langone Genome PACT is a single-site assay performed at NYU Langone Health.
    Device Description
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