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

    TOBRAMYCIN 125I RIA KIT

    K Number: K780182 · Decision Feb 13, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    18
    Review Days
    10

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    Basic Information

    Device Name
    TOBRAMYCIN 125I RIA KIT
    K Number
    K780182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    New England Nuclear
    Date Received
    February 3, 1978
    Decision Date
    February 13, 1978
    Product Code
    DID
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DID Bacillus Subtilis Microbiology Assay, Tobramycin

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