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

    PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)

    K Number: K023795 · Decision Jan 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    21
    Applicant Total
    50
    Review Days
    69

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    Basic Information

    Device Name
    PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)
    K Number
    K023795
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3700
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lin-Zhi International, Inc.
    Date Received
    November 13, 2002
    Decision Date
    January 21, 2003
    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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