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

    TEST SET, 125 I-DIGOXIN

    K Number: K781834 · Decision Jan 3, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    13
    Review Days
    65

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    Basic Information

    Device Name
    TEST SET, 125 I-DIGOXIN
    K Number
    K781834
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Wien Laboratories, Inc.
    Date Received
    October 30, 1978
    Decision Date
    January 3, 1979
    Product Code
    DNL
    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
    DNL Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.

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