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

    Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer

    K Number: K191030 · Decision Feb 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    7
    Review Days
    309

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    Basic Information

    Device Name
    Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer
    K Number
    K191030
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.2570
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Life Technologies Corporation
    Date Received
    April 18, 2019
    Decision Date
    February 21, 2020
    Product Code
    PCA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PCA Dna Genetic Analyzer

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