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

    VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE

    K Number: K981314 · Decision Sep 4, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    62
    Applicant Total
    17
    Review Days
    147

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    Basic Information

    Device Name
    VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
    K Number
    K981314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3620
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sun Biomedical Laboratories, Inc.
    Date Received
    April 10, 1998
    Decision Date
    September 4, 1998
    Product Code
    DJR
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DJR Enzyme Immunoassay, Methadone

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    Other Clearances by Sun Biomedical Laboratories, Inc.

    K Number Device Name
    K023856 VISUALINE METHADONE DIPSTRIPTEST
    K023648 VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
    K014089 VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
    K020136 VISUALINE BARBITURATES DIPSTRIP TEST
    K011499 VISUALINE AMPHETAMINE DIPSTRIP ASSAY
    K010177 VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
    K993485 VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE
    K983790 VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE
    K972032 VISUALINE II METHAMPHETIMINE
    K963606 VISUALINE COMBO V (COCAINE/THC) TEST
    Search all 17 clearances from Sun Biomedical Laboratories, Inc. →