BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DE-TOX TUBES A AND DE-TOX TUBES B

    K Number: K904326 · Decision Jan 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    119

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    Basic Information

    Device Name
    DE-TOX TUBES A AND DE-TOX TUBES B
    K Number
    K904326
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2270
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Dyna-Tek Industries
    Date Received
    September 20, 1990
    Decision Date
    January 17, 1991
    Product Code
    DPA
    Advisory Committee
    Clinical Chemistry
    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
    DPA Apparatus, General Use, Thin Layer Chromatography

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    Other Clearances by Dyna-Tek Industries

    K Number Device Name
    K964771 DE-TOX CONTROL 1 AND DE-TOX CONTROL 19