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

    DIGOCTK 125

    K Number: K800773 · Decision Apr 24, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    14
    Applicant Total
    20
    Review Days
    17

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    Basic Information

    Device Name
    DIGOCTK 125
    K Number
    K800773
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Sorin Biomedica, Fiat, USA, Inc.
    Date Received
    April 7, 1980
    Decision Date
    April 24, 1980
    Product Code
    LCS
    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
    LCS Radioimmunoassay, Digoxin (125-I)

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