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

    EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95

    K Number: K881337 · Decision May 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    122
    Applicant Total
    288
    Review Days
    59

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    Basic Information

    Device Name
    EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
    K Number
    K881337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    March 29, 1988
    Decision Date
    May 27, 1988
    Product Code
    DLJ
    Advisory Committee
    Clinical Toxicology
    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
    DLJ Calibrators, Drug Specific

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    K935177 GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
    K935136 CHOLESTEROL (CHOL) TEST ITEM NO. 65410
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