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

    CEDIA DAU PROPOXYPHENE ASSAY

    K Number: K951133 · Decision May 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    21
    Applicant Total
    107
    Review Days
    50

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    Basic Information

    Device Name
    CEDIA DAU PROPOXYPHENE ASSAY
    K Number
    K951133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3700
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microgenics Corp.
    Date Received
    March 13, 1995
    Decision Date
    May 2, 1995
    Product Code
    JXN
    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
    JXN Enzyme Immunoassay, Propoxyphene

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