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

    Cepheid Xpert Respiratory Control Panel

    K Number: K190086 · Decision Oct 7, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    30
    Applicant Total
    18
    Review Days
    263

    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
    Cepheid Xpert Respiratory Control Panel
    K Number
    K190086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3920
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microbiologics, Inc.
    Date Received
    January 17, 2019
    Decision Date
    October 7, 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

    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

    FilmArray GI Control Panel M238

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control

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

    Other Clearances by Microbiologics, Inc.

    K Number Device Name
    K191168 Cepheid Xpert SA Nasal Complete Control Panel
    K191172 Cepheid Xpert MRSA NxG Control Panel
    K190223 Cepheid Xpert CT/NG Control Panel
    K190463 Cepheid Xpert C. difficile/Epi Control Panel
    K182472 Cepheid Xpert GBS LB Control Panel
    K181683 BD MAX CT/GC/TV 20-Day QC Panel
    K181711 BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
    K970009 LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
    K954812 LYFO(TM) DIFFERIENTAL DISK-PYR
    K951889 LYFO(TM) DIFFERENTIAL DISK
    Search all 18 clearances from Microbiologics, Inc. →