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

    VALPROIC ACID (FPIA) KIT

    K Number: K895569 · Decision Oct 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    34
    Applicant Total
    9
    Review Days
    27

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    Basic Information

    Device Name
    VALPROIC ACID (FPIA) KIT
    K Number
    K895569
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Tudor Laboratories, Inc.
    Date Received
    September 6, 1989
    Decision Date
    October 3, 1989
    Product Code
    LEG
    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
    LEG Enzyme Immunoassay, Valproic Acid

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    Other Clearances by Tudor Laboratories, Inc.

    K Number Device Name
    K921904 THYROXINE (FPIA) KIT
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    K895572 N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT
    K895571 N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT
    K895567 PRIMIDONE (FPIA) KIT
    K895570 VALPROIC ACID (FPIA) CALIBRATOR KIT
    K895568 PRIMIDONE (FPIA) CALIBRATOR KIT