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

    SERODOT TOXOPLASMA IGG TEST KIT

    K Number: K875363 · Decision Apr 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    105
    Applicant Total
    20
    Review Days
    112

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    Basic Information

    Device Name
    SERODOT TOXOPLASMA IGG TEST KIT
    K Number
    K875363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Disease Detection International, Inc.
    Date Received
    December 31, 1987
    Decision Date
    April 21, 1988
    Product Code
    LGD
    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
    LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

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