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

    TRACE MICROPROTEIN REAGENT

    K Number: K925794 · Decision Mar 29, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    12
    Applicant Total
    22
    Review Days
    133

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    Basic Information

    Device Name
    TRACE MICROPROTEIN REAGENT
    K Number
    K925794
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trace America, Inc.
    Date Received
    November 16, 1992
    Decision Date
    March 29, 1993
    Product Code
    JGQ
    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
    JGQ Turbidimetric, Total Protein

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    K972297 AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    K971477 UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
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