BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    QUICKLAB RSV

    K Number: K021789 · Decision Nov 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    173

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    Basic Information

    Device Name
    QUICKLAB RSV
    K Number
    K021789
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3480
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integrated Biotechnology Corp.
    Date Received
    May 31, 2002
    Decision Date
    November 20, 2002
    Product Code
    GQG
    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
    GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

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