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

    DE-TOX CONTROL 1 AND DE-TOX CONTROL 19

    K Number: K964771 · Decision Feb 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    2
    Review Days
    69

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    Basic Information

    Device Name
    DE-TOX CONTROL 1 AND DE-TOX CONTROL 19
    K Number
    K964771
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dyna-Tek Industries
    Date Received
    November 27, 1996
    Decision Date
    February 4, 1997
    Product Code
    DIF
    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
    DIF Drug Mixture Control Materials

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    Other Clearances by Dyna-Tek Industries

    K Number Device Name
    K904326 DE-TOX TUBES A AND DE-TOX TUBES B