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

    STAPHAUREX ZL30

    K Number: K851949 · Decision May 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    28
    Review Days
    19

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    Basic Information

    Device Name
    STAPHAUREX ZL30
    K Number
    K851949
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Wellcome Diagnostics
    Date Received
    May 3, 1985
    Decision Date
    May 22, 1985
    Product Code
    GTN
    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
    GTN Antisera, Fluorescent, All Types, Staphylococcus Spp.

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