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

    RIA TEST KIT, CENTRIA DIGOXIN

    K Number: K790540 · Decision Apr 23, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    9
    Applicant Total
    82
    Review Days
    34

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    Basic Information

    Device Name
    RIA TEST KIT, CENTRIA DIGOXIN
    K Number
    K790540
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Ventrex Laboratories, Inc.
    Date Received
    March 20, 1979
    Decision Date
    April 23, 1979
    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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