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

    REMEDI HS DRUG PROFILING SYSTEM

    K Number: K941596 · Decision Mar 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    319
    Review Days
    360

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    Basic Information

    Device Name
    REMEDI HS DRUG PROFILING SYSTEM
    K Number
    K941596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad
    Date Received
    April 1, 1994
    Decision Date
    March 27, 1995
    Product Code
    DNI
    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
    DNI Liquid Chromatography, Amphetamine

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