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

    URINE AMPHETAMINE DIRECT RIA KIT (I-125)

    K Number: K913866 · Decision Sep 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    8
    Applicant Total
    50
    Review Days
    29

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    Basic Information

    Device Name
    URINE AMPHETAMINE DIRECT RIA KIT (I-125)
    K Number
    K913866
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Immunalysis Corporation
    Date Received
    August 27, 1991
    Decision Date
    September 25, 1991
    Product Code
    DJP
    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
    DJP Radioimmunoassay, Amphetamine

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