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

    AMES TDA ETHOSUXIMIDE TEST

    K Number: K823801 · Decision Jan 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    158
    Review Days
    28

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    Basic Information

    Device Name
    AMES TDA ETHOSUXIMIDE TEST
    K Number
    K823801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3380
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Miles Laboratories, Inc.
    Date Received
    December 17, 1982
    Decision Date
    January 14, 1983
    Product Code
    DLF
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    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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