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

    I-125 LABELED DIGOXIN

    K Number: K803047 · Decision Dec 22, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    14
    Applicant Total
    29
    Review Days
    21

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    Basic Information

    Device Name
    I-125 LABELED DIGOXIN
    K Number
    K803047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Pcl-Ria, Inc.
    Date Received
    December 1, 1980
    Decision Date
    December 22, 1980
    Product Code
    LCS
    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
    LCS Radioimmunoassay, Digoxin (125-I)

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    Other Clearances by Pcl-Ria, Inc.

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    K820886 THYROXINE T4 KIT
    K820358 FOLLICLE STIMULATING HORMONE KIT
    K820357 LUTEINIZING HORMONE KIT
    K812666 THYROXINE (T4) 125I
    K810867 FOLLICLE STIMULATING HORMONE (FSH)
    K810852 FOLLICLE STIMULATING HORMONE ANTISERUM
    Search all 29 clearances from Pcl-Ria, Inc. →