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

    RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO

    K Number: K770365 · Decision Feb 24, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    206
    Review Days
    1

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    Basic Information

    Device Name
    RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO
    K Number
    K770365
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    February 23, 1977
    Decision Date
    February 24, 1977
    Product Code
    DPO
    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
    DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.

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