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

    TOBRAMYCIN RIA KIT

    K Number: K800743 · Decision Apr 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    16
    Review Days
    13

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    Basic Information

    Device Name
    TOBRAMYCIN RIA KIT
    K Number
    K800743
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Antibodies, Inc.
    Date Received
    April 3, 1980
    Decision Date
    April 16, 1980
    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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