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

    PRIMIDONE (FPIA) CALIBRATOR KIT

    K Number: K895568 · Decision Sep 28, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    122
    Applicant Total
    9
    Review Days
    22

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    Basic Information

    Device Name
    PRIMIDONE (FPIA) CALIBRATOR KIT
    K Number
    K895568
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Tudor Laboratories, Inc.
    Date Received
    September 6, 1989
    Decision Date
    September 28, 1989
    Product Code
    DLJ
    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
    DLJ Calibrators, Drug Specific

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