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

    REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION

    K Number: K911954 · Decision May 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    62
    Applicant Total
    319
    Review Days
    22

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    Basic Information

    Device Name
    REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION
    K Number
    K911954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3620
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bio-Rad
    Date Received
    May 1, 1991
    Decision Date
    May 23, 1991
    Product Code
    DJR
    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
    DJR Enzyme Immunoassay, Methadone

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