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

    EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93

    K Number: K864894 · Decision Jan 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    7
    Applicant Total
    288
    Review Days
    25

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    Basic Information

    Device Name
    EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
    K Number
    K864894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3040
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    December 15, 1986
    Decision Date
    January 9, 1987
    Product Code
    DMT
    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
    DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

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