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

    STAPHYLASE TEST

    K Number: K874303 · Decision Nov 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    93
    Review Days
    17

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    Basic Information

    Device Name
    STAPHYLASE TEST
    K Number
    K874303
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Oxoid U.S.A., Inc.
    Date Received
    October 20, 1987
    Decision Date
    November 6, 1987
    Product Code
    LHT
    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
    LHT Staphylococcus Aureus Somatic Antigens

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