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

    VALPROIC ACID EIA TEST

    K Number: K961988 · Decision Jul 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    34
    Applicant Total
    66
    Review Days
    56

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    Basic Information

    Device Name
    VALPROIC ACID EIA TEST
    K Number
    K961988
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Reagents, Inc.
    Date Received
    May 21, 1996
    Decision Date
    July 16, 1996
    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 Diagnostic Reagents, Inc.

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    K983159 DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
    K973102 LIDOCAINE EIA ASSAY
    K972835 50NG/ML COCAINE METABOLITE CALIBRATOR
    K972526 METHADONE EIA ASSAY
    K964212 QUINIDINE ENZYME IMMUNOASSAY
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