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

    ABUSCREEN FP FOR PHENCYCLIDINE

    K Number: K890882 · Decision Mar 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    296
    Review Days
    22

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    Basic Information

    Device Name
    ABUSCREEN FP FOR PHENCYCLIDINE
    K Number
    K890882
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    February 21, 1989
    Decision Date
    March 15, 1989
    Product Code
    LCL
    Advisory Committee
    Unknown
    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
    LCL Radioimmunoassay, Phencyclidine

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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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