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

    TOXI CHEM SERUM ALCOHOL CONTROL

    K Number: K833514 · Decision Dec 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    10
    Applicant Total
    16
    Review Days
    58

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    Basic Information

    Device Name
    TOXI CHEM SERUM ALCOHOL CONTROL
    K Number
    K833514
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Fisher Diagnostics
    Date Received
    October 11, 1983
    Decision Date
    December 8, 1983
    Product Code
    DKC
    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
    DKC Alcohol Control Materials

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