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

    Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit

    K Number: K233453 · Decision Jul 10, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    10
    Applicant Total
    7
    Review Days
    264

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    Basic Information

    Device Name
    Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit
    K Number
    K233453
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3981
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Life Technologies Corporation
    Date Received
    October 20, 2023
    Decision Date
    July 10, 2024
    Product Code
    QQX
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

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    Other Clearances by Life Technologies Corporation

    K Number Device Name
    K241806 Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
    K191030 Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer
    K170299 Ion PGM Dx System
    K123955 QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
    K103302 STEMPRO MSC SFM
    K100616 KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618