BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ZEUS IFA(TM) nDNA Test System, ZEUS dIFine

    K Number: K231616 · Decision Aug 31, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
    K Number
    K231616
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zeus Scientific
    Date Received
    June 2, 2023
    Decision Date
    August 31, 2023
    Product Code
    KTL
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KTL Anti-Dna Indirect Immunofluorescent Solid Phase

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