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

    ON.SITE ALCOHOL

    K Number: K963197 · Decision Sep 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    35

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    Basic Information

    Device Name
    ON.SITE ALCOHOL
    K Number
    K963197
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3040
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ansys, Inc.
    Date Received
    August 15, 1996
    Decision Date
    September 19, 1996
    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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