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

    CENTRIFICHEM ALBUMIN

    K Number: K802436 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    119
    Applicant Total
    69
    Review Days
    25

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    Basic Information

    Device Name
    CENTRIFICHEM ALBUMIN
    K Number
    K802436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Union Carbide Corp.
    Date Received
    October 6, 1980
    Decision Date
    October 31, 1980
    Product Code
    CIX
    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
    CIX Bromcresol Green Dye-Binding, Albumin

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    Other Clearances by Union Carbide Corp.

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    K812536 LINDE MARK II
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    K810596 CENTRIFI CHEM SYSTEM 400 ANALYZER
    K810129 CENTRIFICHEM SYSTEM 500
    K803216 CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT
    K802741 CENTRIFICHEM COMB. SERUM-BASED CALIB.
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