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

    FilmArray GI Control Panel M238

    K Number: K251526 · Decision Aug 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    30
    Applicant Total
    15
    Review Days
    87

    Basic Information

    Device Name
    FilmArray GI Control Panel M238
    K Number
    K251526
    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
    May 19, 2025
    Decision Date
    August 14, 2025
    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

    Similar 510(k) Clearances

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

    FilmArray TF Control Panel M527

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MDx-Chex for BCP

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MDx-Chex for BCN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MDx-Chex for BCY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

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

    Other Clearances by Maine Molecular Quality Controls, Inc.

    K Number Device Name
    K260577 FilmArray TF Control Panel M527
    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
    K190222 FilmArray Pneumonia/Pneumoniaplus Control
    K173171 FilmArray RP2/RP2plus Control Panel
    Search all 15 clearances from Maine Molecular Quality Controls, Inc. →