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

    CEDIA DIGOXIN II

    K Number: K970883 · Decision May 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    84
    Applicant Total
    340
    Review Days
    72

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    Basic Information

    Device Name
    CEDIA DIGOXIN II
    K Number
    K970883
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    March 10, 1997
    Decision Date
    May 21, 1997
    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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