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

    INNOFLUOR(TM) VALPROIC ACID REAGENT SET

    K Number: K911688 · Decision Jul 5, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    34
    Applicant Total
    6
    Review Days
    80

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    Basic Information

    Device Name
    INNOFLUOR(TM) VALPROIC ACID REAGENT SET
    K Number
    K911688
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Bioclinical, Inc.
    Date Received
    April 16, 1991
    Decision Date
    July 5, 1991
    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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