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

    EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95

    K Number: K882766 · Decision Aug 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    6
    Applicant Total
    288
    Review Days
    48

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    Basic Information

    Device Name
    EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
    K Number
    K882766
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2250
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    July 6, 1988
    Decision Date
    August 23, 1988
    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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