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

    ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE

    K Number: K040445 · Decision May 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    21
    Applicant Total
    85
    Review Days
    89

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    Basic Information

    Device Name
    ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
    K Number
    K040445
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3700
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ACON Laboratories, Inc.
    Date Received
    February 20, 2004
    Decision Date
    May 19, 2004
    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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