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

    BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY

    K Number: K952839 · Decision Aug 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    340
    Review Days
    64

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    Basic Information

    Device Name
    BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY
    K Number
    K952839
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3040
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    June 21, 1995
    Decision Date
    August 24, 1995
    Product Code
    DML
    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
    DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method

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