BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA

    K Number: K051969 · Decision Oct 3, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    9
    Applicant Total
    6
    Review Days
    75

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA
    K Number
    K051969
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1165
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ibl GmbH
    Date Received
    July 20, 2005
    Decision Date
    October 3, 2005
    Product Code
    CHQ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CHQ Chromatographic/Fluorometric Method, Catecholamines

    Similar 510(k) Clearances

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

    ESA PLASMA FREE METANEPHRINE ANALYSIS KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PLASMA CATECHOLAMINE KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MODEL 5500 CEAS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    URINARY METANEPHRINE KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    URINARY CATECHOLAMINE KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Ibl GmbH

    K Number Device Name
    K041349 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
    K040923 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
    K033786 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA
    K032796 IBL C3D-CIC EIA TEST
    K032254 IBL C1Q-CIC CIA TEST