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

    IGD DIAGNOSTIC TEST KITS

    K Number: K051299 · Decision Nov 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    189

    Basic Information

    Device Name
    IGD DIAGNOSTIC TEST KITS
    K Number
    K051299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    THE BINDING SITE LTD.
    Date Received
    May 18, 2005
    Decision Date
    November 23, 2005
    Product Code
    CZJ
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CZJ Igd, Antigen, Antiserum, Control

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CZJ), ordered by most recent decision date.

    HUMAN IGD KIT FOR USE ON SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    HUMAN IGD IMMUNOLOGICAL NL TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    QM300 CALIBRATOR D PACK

    FDA 510(k)
    FDA Class 2 ·Immunology

    TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410

    FDA 510(k)
    FDA Class 2 ·Immunology

    DETERM. SIZE 72 RADIAL-HUMAN IGD

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all