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

    SIGMA DIAGNOSTICS BUN REAGENT

    K Number: K963537 · Decision Oct 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    164
    Review Days
    50

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    Basic Information

    Device Name
    SIGMA DIAGNOSTICS BUN REAGENT
    K Number
    K963537
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    September 4, 1996
    Decision Date
    October 24, 1996
    Product Code
    LFP
    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
    LFP Conductivity Rate, Urea Nitrogen

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