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

    PHENOBARBITAL FLEX REAGENT CARTRIDGE

    K Number: K944932 · Decision Dec 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    34
    Applicant Total
    28
    Review Days
    83

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    Basic Information

    Device Name
    PHENOBARBITAL FLEX REAGENT CARTRIDGE
    K Number
    K944932
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dupont Medical Products
    Date Received
    October 6, 1994
    Decision Date
    December 28, 1994
    Product Code
    DLZ
    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
    DLZ Enzyme Immunoassay, Phenobarbital

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