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

    INNOFLOUR GENTAMICIN

    K Number: K841865 · Decision May 31, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    27

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    Basic Information

    Device Name
    INNOFLOUR GENTAMICIN
    K Number
    K841865
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Innotron Diagnostics
    Date Received
    May 4, 1984
    Decision Date
    May 31, 1984
    Product Code
    LCQ
    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
    LCQ Fluorescent Immunoassay Gentamicin

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    Other Clearances by Innotron Diagnostics

    K Number Device Name
    K850629 INNOFLUOR THEOPHYLLINE
    K844721 INNOFLUOR PRIMIDONE
    K841866 INNOFLOUR TOBRAMYCIN
    K841707 INNOFLUOR PHENOBARBITAL
    K841706 INNOFLUOR PHENYTOIN