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

    LYME IGM MICROASSAY

    K Number: K900572 · Decision May 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    110
    Applicant Total
    68
    Review Days
    84

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    Basic Information

    Device Name
    LYME IGM MICROASSAY
    K Number
    K900572
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Diamedix Corp.
    Date Received
    February 7, 1990
    Decision Date
    May 2, 1990
    Product Code
    LSR
    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
    LSR Reagent, Borrelia Serological Reagent

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