BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4

    K Number: K911613 · Decision Jun 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    43
    Review Days
    86

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    Basic Information

    Device Name
    VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4
    K Number
    K911613
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Exmoor Plastics , Ltd.
    Date Received
    April 3, 1991
    Decision Date
    June 28, 1991
    Product Code
    LCR
    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
    LCR Fluorescent Immunoassay, Tobramycin

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