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

    MILENIA COCAINE METABOLITE

    K Number: K910044 · Decision Feb 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    321
    Review Days
    40

    Basic Information

    Device Name
    MILENIA COCAINE METABOLITE
    K Number
    K910044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    DIAGNOSTIC PRODUCTS CORP.
    Date Received
    January 4, 1991
    Decision Date
    February 13, 1991
    Product Code
    KLN
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KLN Radioimmunoassay, Cocaine Metabolite

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