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

    RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS

    K Number: K003809 · Decision Apr 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    4
    Review Days
    133

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    Basic Information

    Device Name
    RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS
    K Number
    K003809
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rapid Diagnostics, Inc.
    Date Received
    December 8, 2000
    Decision Date
    April 20, 2001
    Product Code
    DKZ
    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
    DKZ Enzyme Immunoassay, Amphetamine

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    Other Clearances by Rapid Diagnostics, Inc.

    K Number Device Name
    K033566 MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
    K020716 RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
    K981770 RAPIDHCG PREGNANCY TEST