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

    125I DIGOXIN RADIOIMMUNOASSAY KIT

    K Number: K821811 · Decision Jul 2, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    9
    Applicant Total
    14
    Review Days
    14

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    Basic Information

    Device Name
    125I DIGOXIN RADIOIMMUNOASSAY KIT
    K Number
    K821811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Cambridge Medical Technology
    Date Received
    June 18, 1982
    Decision Date
    July 2, 1982
    Product Code
    DPB
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DPB Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.

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