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

    KALLESTAD QUANTICOAT 125 DIGOXIN

    K Number: K811776 · Decision Jul 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    92
    Review Days
    17

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    Basic Information

    Device Name
    KALLESTAD QUANTICOAT 125 DIGOXIN
    K Number
    K811776
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Laboratories, Inc.
    Date Received
    June 23, 1981
    Decision Date
    July 10, 1981
    Product Code
    DPO
    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
    DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.

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