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

    FilmArray Pneumonia/Pneumoniaplus Control

    K Number: K190222 · Decision May 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    30
    Applicant Total
    15
    Review Days
    87

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    Basic Information

    Device Name
    FilmArray Pneumonia/Pneumoniaplus Control
    K Number
    K190222
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3920
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maine Molecular Quality Controls, Inc.
    Date Received
    February 5, 2019
    Decision Date
    May 3, 2019
    Product Code
    PMN
    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
    PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

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    Other Clearances by Maine Molecular Quality Controls, Inc.

    K Number Device Name
    K260577 FilmArray TF Control Panel M527
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    K241289 SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
    K233611 SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
    K230868 SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
    K221253 SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
    K203680 BioFire JI Control Panel M420
    K202196 BioFire RP2.1/RP2.1plus Control Panel M441
    K200010 FilmArray BCID2 Control Panel M416
    K173171 FilmArray RP2/RP2plus Control Panel
    Search all 15 clearances from Maine Molecular Quality Controls, Inc. →