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

    DIGOXIN RADIOIMMUNOASSAY

    K Number: K820274 · Decision Feb 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    9
    Applicant Total
    39
    Review Days
    21

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    Basic Information

    Device Name
    DIGOXIN RADIOIMMUNOASSAY
    K Number
    K820274
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Diagnostic Corp.
    Date Received
    February 2, 1982
    Decision Date
    February 23, 1982
    Product Code
    DPB
    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
    DPB Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.

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