BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GRAM-NEGATIVE QUICKFISH BC

    K Number: K123418 · Decision Jul 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    48
    Applicant Total
    21
    Review Days
    257

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    Basic Information

    Device Name
    GRAM-NEGATIVE QUICKFISH BC
    K Number
    K123418
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Advandx, Inc.
    Date Received
    November 6, 2012
    Decision Date
    July 21, 2013
    Product Code
    JSS
    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
    JSS Kit, Identification, Enterobacteriaceae

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    Other Clearances by Advandx, Inc.

    K Number Device Name
    K140619 MECA XPRESSFISH
    K121991 ENTEROCOCCUS QUICKFISH BC
    K113371 STAPHYLOCOCCUS QUICKFISH BC
    K101558 GNR TRAFFIC LIGHT PNA FISH
    K093024 YEAST TRAFFIC LIGHT PNA FISH
    K092784 C. ALBICANS/C. GLABRATA PNA FISH
    K092655 C. ALBICANS PNA FISH
    K092236 E.COLI/P. AERUGINOSA PNA FISH
    K092166 S. AUREUS/CNS PNA FISH, MODEL KT005
    K092393 EK/P. AERUGINOSA PNA FISH
    Search all 21 clearances from Advandx, Inc. →