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

    VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY

    K Number: K951799 · Decision Mar 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    19
    Review Days
    336

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    Basic Information

    Device Name
    VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
    K Number
    K951799
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Light Diagnostics
    Date Received
    April 19, 1995
    Decision Date
    March 20, 1996
    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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