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

    IN-VITRO TEST DETERMINATION OF TOBRAMYCIN

    K Number: K854184 · Decision Dec 4, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    36
    Review Days
    50

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    Basic Information

    Device Name
    IN-VITRO TEST DETERMINATION OF TOBRAMYCIN
    K Number
    K854184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Clinical Data, Inc.
    Date Received
    October 15, 1985
    Decision Date
    December 4, 1985
    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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