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

    OPUS(TM) DIGOXIN TEST SYSTEM

    K Number: K901547 · Decision Jun 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    84
    Applicant Total
    35
    Review Days
    84

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    Basic Information

    Device Name
    OPUS(TM) DIGOXIN TEST SYSTEM
    K Number
    K901547
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Pb Diagnostic Systems, Inc.
    Date Received
    April 3, 1990
    Decision Date
    June 26, 1990
    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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