BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TOX PERFECT B TUBES AND REAGENTS

    K Number: K952501 · Decision Aug 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    7
    Review Days
    86

    Basic Information

    Device Name
    TOX PERFECT B TUBES AND REAGENTS
    K Number
    K952501
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    CHIMERA RESEARCH & CHEMICAL, INC.
    Date Received
    May 30, 1995
    Decision Date
    August 24, 1995
    Product Code
    DPM
    Advisory Committee
    Clinical Chemistry
    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
    DPM Columns, Liquid Chromatography

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