BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Enzyme Immunoassay, Fetal Fibronectin

    PMA: P920048 · Supplement: S019 · Decision May 21, 2021
    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
    PMA Number
    P920048
    Supplement Number
    S019
    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
    May 21, 2021
    Date Received
    October 30, 2020
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at 10210 Genetic Center Dr., San Diego, CA 92121 (GCD), for the manufacture of finished, kitted Rapid fFN Cassettes for use in the TLiIQ System.

    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