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

    TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)

    K Number: K920314 · Decision Apr 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    10
    Review Days
    85

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    Basic Information

    Device Name
    TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)
    K Number
    K920314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syntex Corp.
    Date Received
    January 23, 1992
    Decision Date
    April 17, 1992
    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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