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

    AMES TDA TM PRIMIDONE TEST

    K Number: K811007 · Decision Apr 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    158
    Review Days
    15

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    Basic Information

    Device Name
    AMES TDA TM PRIMIDONE TEST
    K Number
    K811007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3680
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Miles Laboratories, Inc.
    Date Received
    April 14, 1981
    Decision Date
    April 29, 1981
    Product Code
    LFT
    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
    LFT Fluorescent Immunoassay, Primidone

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