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

    AMES TDA PRIMIDONE TEST

    K Number: K802654 · Decision Nov 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    158
    Review Days
    19

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    Basic Information

    Device Name
    AMES TDA PRIMIDONE TEST
    K Number
    K802654
    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
    October 24, 1980
    Decision Date
    November 12, 1980
    Product Code
    DJD
    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
    DJD Enzyme Immunoassay, Primidone

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