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

    DIGOXIN RADIOIMMUNOASSAY SYSTEM

    K Number: K792153 · Decision Nov 13, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    9
    Applicant Total
    9
    Review Days
    18

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    Basic Information

    Device Name
    DIGOXIN RADIOIMMUNOASSAY SYSTEM
    K Number
    K792153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Radioimmunoassay, Inc.
    Date Received
    October 26, 1979
    Decision Date
    November 13, 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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    Other Clearances by Radioimmunoassay, Inc.

    K Number Device Name
    K802135 TESTOSTERONE RADIOIMMUNOASSY KIT
    K800106 LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS
    K800107 FOLLICLE STIMULATING HORMONE
    K792539 TRIIODOTHYRONINE RIA SYSTEM
    K792154 THYROID STIMULATING HORMONE
    K792036 CORTISOL RADIOIMMUNOASSAY SYSTEM
    K780671 125 I-T3 UPTAKE REAGENT
    K780672 125 I-T4 RIA REAGENT