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

    KODAK EKTA-CHEM CLINICAL CHEM. SLIDES

    K Number: K802376 · Decision Oct 23, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    238
    Review Days
    23

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    Basic Information

    Device Name
    KODAK EKTA-CHEM CLINICAL CHEM. SLIDES
    K Number
    K802376
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Eastman Kodak Company
    Date Received
    September 30, 1980
    Decision Date
    October 23, 1980
    Product Code
    CHS
    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
    CHS Coulometric Method, Carbon-Dioxide

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