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

    MECA XPRESSFISH

    K Number: K140619 · Decision Oct 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    9
    Applicant Total
    21
    Review Days
    213

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MECA XPRESSFISH
    K Number
    K140619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advandx, Inc.
    Date Received
    March 11, 2014
    Decision Date
    October 10, 2014
    Product Code
    MYI
    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
    MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MYI), ordered by most recent decision date.

    ALERE PBP2A SA/CONS CULTURE COLONY TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ALERE PBP2A TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BINAXNOW PBP2A TEST, MODEL 890-000

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CLEARVIEW EXACT PBP2A TEST, MODEL 891-000

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MASTALEX -MRSA, MODEL RST501

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OXOID PBP2 1 LATEX AGGLUTINATION TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Advandx, Inc.

    K Number Device Name
    K123418 GRAM-NEGATIVE QUICKFISH BC
    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. →