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

    EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647

    K Number: K881607 · Decision Jun 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    288
    Review Days
    50

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    Basic Information

    Device Name
    EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647
    K Number
    K881607
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3380
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    April 12, 1988
    Decision Date
    June 1, 1988
    Product Code
    DLF
    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
    DLF Enzyme Immunoassay, Ethosuximide

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