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

    QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM

    K Number: K023058 · Decision Oct 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    84
    Applicant Total
    2
    Review Days
    41

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    Basic Information

    Device Name
    QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
    K Number
    K023058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seradyn
    Date Received
    September 13, 2002
    Decision Date
    October 24, 2002
    Product Code
    KXT
    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
    KXT Enzyme Immunoassay, Digoxin

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    Other Clearances by Seradyn

    K Number Device Name
    K030405 QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075