BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇫🇷 France

    VIDAS C DIFFICILE GDH

    K Number: K132010 · Decision Oct 9, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    9
    Applicant Total
    16
    Review Days
    100

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    Basic Information

    Device Name
    VIDAS C DIFFICILE GDH
    K Number
    K132010
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomerieux S.A.
    Date Received
    July 1, 2013
    Decision Date
    October 9, 2013
    Product Code
    MCB
    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
    MCB Antigen, C. Difficile

    Similar 510(k) Clearances

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    TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A

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    MERITEC C. DIFFICILE CONTROLS

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    Other Clearances by Biomerieux S.A.

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    K192050 ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
    K191953 ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
    K190154 ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
    K183031 ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
    K181092 CHROMID CARBA agar (CARB)
    K180936 ETEST Telavancin (TLA) (0.002-32 ug/mL)
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