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

    QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO

    K Number: K791502 · Decision Sep 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    319
    Review Days
    27

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    Basic Information

    Device Name
    QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO
    K Number
    K791502
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Bio-Rad
    Date Received
    August 8, 1979
    Decision Date
    September 4, 1979
    Product Code
    KLB
    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
    KLB Radioimmunoassay, Tobramycin

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