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

    THEOPHYLLINE RIASSAY

    K Number: K792062 · Decision Feb 25, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    7
    Review Days
    133

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    Basic Information

    Device Name
    THEOPHYLLINE RIASSAY
    K Number
    K792062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Ria Diagnostics
    Date Received
    October 15, 1979
    Decision Date
    February 25, 1980
    Product Code
    LCA
    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
    LCA Radioimmunoassay, Theophylline

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    Other Clearances by Ria Diagnostics

    K Number Device Name
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    K852537 T-3 RIASSAY
    K810296 DIGOXIN RIA ASSAY
    K801691 TSH RIASSAY
    K780012 ANTITHROMBIN III RIA