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

    ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE

    K Number: K050593 · Decision May 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    85
    Review Days
    59

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    Basic Information

    Device Name
    ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
    K Number
    K050593
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ACON Laboratories, Inc.
    Date Received
    March 8, 2005
    Decision Date
    May 6, 2005
    Product Code
    DIS
    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
    DIS Enzyme Immunoassay, Barbiturate

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