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

    INNOFLUOR GENTAMICIN ASSAY SYSTEM

    K Number: K955569 · Decision Feb 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    11
    Review Days
    65

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    Basic Information

    Device Name
    INNOFLUOR GENTAMICIN ASSAY SYSTEM
    K Number
    K955569
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oxis Intl., Inc.
    Date Received
    December 6, 1995
    Decision Date
    February 9, 1996
    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 Oxis Intl., Inc.

    K Number Device Name
    K972331 INNOFLUOR GENTAMICIN ASSAY SYSTEM
    K972330 INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
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    K970509 INNOFLOUR CALIBRATOR REAGENT SET
    K970517 INNOFLUOR TOPIRAMATE CONTROL SET
    K955568 INNOFLUOR QUINIDINE ASSAY SYSTEM
    K955570 INNOFLUOR AMIKACIN ASSAY SYSTEM
    K955567 INNOFLUOR THEOPHYLLINE ASSAY SYSTEM
    K955562 INNOFLUOR PHENYTOIN ASSAY SYSTEM
    K950346 B-L RED(TM) DISCS
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