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

    KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)

    K Number: K812027 · Decision Aug 3, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    7
    Applicant Total
    238
    Review Days
    14

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    Basic Information

    Device Name
    KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
    K Number
    K812027
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Eastman Kodak Company
    Date Received
    July 20, 1981
    Decision Date
    August 3, 1981
    Product Code
    CIW
    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
    CIW Starch-Dye Bound Polymer, Amylase

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