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

    CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY

    K Number: K863363 · Decision Nov 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    105
    Applicant Total
    10
    Review Days
    72

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    Basic Information

    Device Name
    CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY
    K Number
    K863363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Cytotech, Inc.
    Date Received
    September 2, 1986
    Decision Date
    November 13, 1986
    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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