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

    BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.

    K Number: K821347 · Decision May 28, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    23

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    Basic Information

    Device Name
    BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.
    K Number
    K821347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Bioclinical Corp.
    Date Received
    May 5, 1982
    Decision Date
    May 28, 1982
    Product Code
    LCA
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LCA Radioimmunoassay, Theophylline

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