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

    URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)

    K Number: K873371 · Decision Jan 5, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    9
    Applicant Total
    319
    Review Days
    137

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    Basic Information

    Device Name
    URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)
    K Number
    K873371
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1165
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bio-Rad
    Date Received
    August 21, 1987
    Decision Date
    January 5, 1988
    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

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