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

    HICHEM BUN REAGENT

    K Number: K992847 · Decision Oct 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    12
    Review Days
    51

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    Basic Information

    Device Name
    HICHEM BUN REAGENT
    K Number
    K992847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elan Holdings, Inc.
    Date Received
    August 24, 1999
    Decision Date
    October 14, 1999
    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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    K992842 HICHEM ISE ELECTROLYTE REFERENCE
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    K992846 HICHEM TOTAL PROTEIN REAGENT
    K992845 HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT
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