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

    PARAMAX ALCOHOL REAGENT

    K Number: K840769 · Decision Apr 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    149
    Review Days
    65

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    Basic Information

    Device Name
    PARAMAX ALCOHOL REAGENT
    K Number
    K840769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3040
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Dade
    Date Received
    February 8, 1984
    Decision Date
    April 13, 1984
    Product Code
    DML
    Advisory Committee
    Clinical Toxicology
    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
    DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method

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