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

    ADVIA Centaur Toxoplasma M (Toxo M)

    K Number: K142826 · Decision Dec 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    105
    Applicant Total
    32
    Review Days
    448

    Basic Information

    Device Name
    ADVIA Centaur Toxoplasma M (Toxo M)
    K Number
    K142826
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Date Received
    September 30, 2014
    Decision Date
    December 22, 2015
    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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