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

    MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE

    K Number: K983704 · Decision Feb 10, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    296
    Review Days
    112

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    Basic Information

    Device Name
    MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
    K Number
    K983704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    October 21, 1998
    Decision Date
    February 10, 1999
    Product Code
    JCM
    Advisory Committee
    Hematology
    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
    JCM Control, Hemoglobin, Abnormal

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    Other Clearances by Roche Diagnostic Systems, Inc.

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    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
    K983174 ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
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