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

    CHEMISTRY ANALYZER REAGENTS

    K Number: K792482 · Decision Jan 11, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    119
    Applicant Total
    8
    Review Days
    53

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    Basic Information

    Device Name
    CHEMISTRY ANALYZER REAGENTS
    K Number
    K792482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Laboratory Products, Inc.
    Date Received
    November 19, 1979
    Decision Date
    January 11, 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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    K803050 SPRAY, SYNTHETIC SMEAR
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