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

    TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR

    K Number: K944371 · Decision Nov 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    9
    Applicant Total
    164
    Review Days
    64

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    Basic Information

    Device Name
    TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR
    K Number
    K944371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    September 7, 1994
    Decision Date
    November 10, 1994
    Product Code
    LFW
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LFW Fluorescence Polarization Immunoassay, Tobramycin

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