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

    FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY

    K Number: K853540 · Decision Feb 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    5
    Review Days
    165

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    Basic Information

    Device Name
    FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY
    K Number
    K853540
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Idt, A Division of Whittaker M.A. Bioproducts
    Date Received
    August 23, 1985
    Decision Date
    February 4, 1986
    Product Code
    GQX
    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
    GQX Antiserum, Cf, Varicella-Zoster

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    Other Clearances by Idt, A Division of Whittaker M.A. Bioproducts

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    K772219 FIAX TEST FOR ANTI-RUBELLA ANTIBODY
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