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

    AMES TDA PHENOBARBITAL TEST

    K Number: K842592 · Decision Aug 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    158
    Review Days
    45

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    Basic Information

    Device Name
    AMES TDA PHENOBARBITAL TEST
    K Number
    K842592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Miles Laboratories, Inc.
    Date Received
    July 3, 1984
    Decision Date
    August 17, 1984
    Product Code
    LET
    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
    LET Fluorescent Immunoassay, Phenobarbital

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