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

    FIAX TEST KIT FOR TOBRAMYCIN QUANTITA

    K Number: K801308 · Decision Jun 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    29
    Review Days
    17

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    Basic Information

    Device Name
    FIAX TEST KIT FOR TOBRAMYCIN QUANTITA
    K Number
    K801308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3900
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Diagnostic Technology
    Date Received
    June 3, 1980
    Decision Date
    June 20, 1980
    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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    Other Clearances by Intl. Diagnostic Technology

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    K843356 FIAX 100 FLUOROMETER
    K842749 FIAX TOTAL IGE TEST KIT
    K842071 FIAX TRANSFERRIN TEST KIT
    K841174 RUBELLA ANTIBODY FLUOROIMMUNOASSAY
    K840867 ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
    K834140 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
    K833984 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL
    Search all 29 clearances from Intl. Diagnostic Technology →