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

    RIA COAT DIGOXIN

    K Number: K833842 · Decision Jan 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    10
    Review Days
    75

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    Basic Information

    Device Name
    RIA COAT DIGOXIN
    K Number
    K833842
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Immuno Assay Corp.
    Date Received
    November 3, 1983
    Decision Date
    January 17, 1984
    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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    Other Clearances by Immuno Assay Corp.

    K Number Device Name
    K833745 RIACOAT T-4
    K820089 TSH (RIA) KIT
    K820074 CORTISOL (RIA) KIT
    K811954 COMBO-FER IRON DIAGNOSTIC
    K811725 TBG DIAGNOSTIC KIT
    K811213 T3 (RIA) KIT
    K811212 DIGOXIN (RIA) KIT
    K810857 T3 UPTAKE KIT
    K810811 T4 RIA KIT