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

    ENZYMUNE-TEST DIGOXIN

    K Number: K821000 · Decision Apr 26, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    16
    Applicant Total
    48
    Review Days
    18

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    Basic Information

    Device Name
    ENZYMUNE-TEST DIGOXIN
    K Number
    K821000
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Icl Scientific
    Date Received
    April 8, 1982
    Decision Date
    April 26, 1982
    Product Code
    DON
    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
    DON Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.

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