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

    RIANEN ASSAY SYSTEM, 125I KIT

    K Number: K781495 · Decision Sep 14, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    18
    Review Days
    15

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    Basic Information

    Device Name
    RIANEN ASSAY SYSTEM, 125I KIT
    K Number
    K781495
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    New England Nuclear
    Date Received
    August 30, 1978
    Decision Date
    September 14, 1978
    Product Code
    DNL
    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
    DNL Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.

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