BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    N-ACETYLPROCAINAMIDE CALIBRATOR

    K Number: K833385 · Decision Dec 16, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    6
    Applicant Total
    253
    Review Days
    78

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    Basic Information

    Device Name
    N-ACETYLPROCAINAMIDE CALIBRATOR
    K Number
    K833385
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2250
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    September 29, 1983
    Decision Date
    December 16, 1983
    Product Code
    DLG
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DLG Coating, Liquid, Glc

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