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

    DIGOXIN RIA KIT

    K Number: K771877 · Decision Oct 21, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    16
    Review Days
    17

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    Basic Information

    Device Name
    DIGOXIN RIA KIT
    K Number
    K771877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Antibodies, Inc.
    Date Received
    October 4, 1977
    Decision Date
    October 21, 1977
    Product Code
    DNJ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DNJ Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.

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