BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Enzyme Immunoassay, Fetal Fibronectin

    PMA: P920048 · Supplement: S013 · Decision Jan 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Enzyme Immunoassay, Fetal Fibronectin
    Trade Name
    Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay
    PMA Number
    P920048
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    LKV
    Generic Name
    ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Toxicology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 28, 2020
    Date Received
    January 2, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a new supplier of a critical component, A137 ascites, that is used in the manufacture of Rapid fFN for the TLiIQ System and Fetal Fibronectin Enzyme Immunoassay.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LKV Enzyme Immunoassay, Fetal Fibronectin