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

    VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

    K Number: K964442 · Decision Dec 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    34
    Applicant Total
    96
    Review Days
    42

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    Basic Information

    Device Name
    VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
    K Number
    K964442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Corp.
    Date Received
    November 6, 1996
    Decision Date
    December 18, 1996
    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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