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

    VARICELLA-ZOSTER(IGG) IFA TEST

    K Number: K841434 · Decision Apr 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    135
    Review Days
    378

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    Basic Information

    Device Name
    VARICELLA-ZOSTER(IGG) IFA TEST
    K Number
    K841434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Zeus Scientific, Inc.
    Date Received
    April 6, 1984
    Decision Date
    April 19, 1985
    Product Code
    GQW
    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
    GQW Antigen, Cf, (Including Cf Control), Varicella-Zoster

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