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

    CIBA CORNING ACS DIGOXIN IMMUNOASSAY

    K Number: K902861 · Decision Sep 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    16
    Applicant Total
    125
    Review Days
    74

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    Basic Information

    Device Name
    CIBA CORNING ACS DIGOXIN IMMUNOASSAY
    K Number
    K902861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    June 28, 1990
    Decision Date
    September 10, 1990
    Product Code
    DON
    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
    DON Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.

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