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

    ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP

    K Number: K854009 · Decision Oct 15, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    8
    Applicant Total
    296
    Review Days
    15

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    Basic Information

    Device Name
    ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
    K Number
    K854009
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    September 30, 1985
    Decision Date
    October 15, 1985
    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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    Other Clearances by Roche Diagnostic Systems, Inc.

    K Number Device Name
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    K983704 MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
    K983556 ABUSCREEN ONLINE BENZ 300 CALIBRATORS
    K983555 ABUSCREEN ONLINE BENZ 200 CALIBRATORS
    K983697 MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
    K983700 MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
    K983701 MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
    K983699 MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
    K983703 MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
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