BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Assay, Interleukin

    PMA: P880040 · Supplement: S003 · Decision Aug 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Assay, Interleukin
    Trade Name
    CELLFREE(R) INTERLEUKIN-2 RECEPTOR* BEAD ASSAT KIT
    PMA Number
    P880040
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    MAN
    Generic Name
    ASSAY, INTERLEUKIN
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 7, 1996
    Date Received
    March 24, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN ADDRESS OF THE MANUFACTURING SITE AND UPDATES AND REVISIONS IN STANDARD OPERATING PROCEDURES AND MANUFACTURING INFORMATION

    Classifications

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

    Product Code Device Name
    MAN Assay, Interleukin