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

    ACA ETHOSURIMIDE TEST PACK

    K Number: K792584 · Decision Dec 31, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    253
    Review Days
    17

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    Basic Information

    Device Name
    ACA ETHOSURIMIDE TEST PACK
    K Number
    K792584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3380
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    December 14, 1979
    Decision Date
    December 31, 1979
    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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