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

    VITEK 2 AST - YEAST FLUCONAZOLE

    K Number: K133817 · Decision Aug 5, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    20
    Applicant Total
    251
    Review Days
    232

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    Basic Information

    Device Name
    VITEK 2 AST - YEAST FLUCONAZOLE
    K Number
    K133817
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    bioMerieux, Inc.
    Date Received
    December 16, 2013
    Decision Date
    August 5, 2014
    Product Code
    NGZ
    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
    NGZ Susceptibility Test Plate, Antifungal

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    Other Clearances by bioMerieux, Inc.

    K Number Device Name
    K260282 VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
    K251579 VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
    K234012 VITEK COMPACT PRO
    K232967 VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
    K232963 VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
    K240279 VIDAS TBI (GFAP, UCH-L1)
    K234000 VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
    K232201 VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
    K230864 VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin
    K222378 VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)
    Search all 251 clearances from bioMerieux, Inc. →