BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    ETEST FOR GEMIFLOXACIN

    K Number: K042390 · Decision Nov 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    64
    Review Days
    78

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    Basic Information

    Device Name
    ETEST FOR GEMIFLOXACIN
    K Number
    K042390
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ab Biodisk
    Date Received
    September 2, 2004
    Decision Date
    November 19, 2004
    Product Code
    JWY
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JWY Manual Antimicrobial Susceptibility Test Systems

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    Other Clearances by Ab Biodisk

    K Number Device Name
    K081325 ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
    K052366 ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
    K042392 DAPTOMYCIN
    K040560 ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
    K021445 ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
    K020748 ETEST ERTAPENEM
    K010363 ETEST MEROPENEM
    K002139 ETEST LINEZOLID
    K001547 ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP
    K000596 ETEST GATIFLOXACIN
    Search all 64 clearances from Ab Biodisk →