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

    CEDIA VALPORIC ACID ASSAY

    K Number: K930734 · Decision Sep 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    34
    Applicant Total
    107
    Review Days
    222

    Basic Information

    Device Name
    CEDIA VALPORIC ACID ASSAY
    K Number
    K930734
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MICROGENICS CORP.
    Date Received
    February 11, 1993
    Decision Date
    September 21, 1993
    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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