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

    NEISSERIA MENINGITIDIS GR. Y

    K Number: K840507 · Decision Mar 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    28
    Review Days
    46

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    Basic Information

    Device Name
    NEISSERIA MENINGITIDIS GR. Y
    K Number
    K840507
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Scientific Device Laboratory, Inc.
    Date Received
    February 6, 1984
    Decision Date
    March 23, 1984
    Product Code
    LSC
    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
    LSC Neisseria Controls

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