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

    VALPROIC ACID

    K Number: K936208 · Decision Mar 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    34
    Applicant Total
    28
    Review Days
    72

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    Basic Information

    Device Name
    VALPROIC ACID
    K Number
    K936208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seradyn, Inc.
    Date Received
    December 29, 1993
    Decision Date
    March 11, 1994
    Product Code
    LEG
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    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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