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510(k) Data Aggregation

    K Number
    K242100

    Validate with FDA (Live)

    Date Cleared
    2025-10-16

    (455 days)

    Product Code
    Regulation Number
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    N/A

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