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

    MDx-Chex for BC-GP

    K Number: K231221 · Decision Jul 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    30
    Applicant Total
    33
    Review Days
    90

    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
    MDx-Chex for BC-GP
    K Number
    K231221
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3920
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Streck
    Date Received
    April 28, 2023
    Decision Date
    July 27, 2023
    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 Streck

    K Number Device Name
    K254166 MDx-Chex for BCN
    K231223 MDx-Chex for BC-GN
    K170091 UA-Cellular Complete
    K160588 XN CHECK BF
    K160586 XN-L CHECK
    K160585 XN CAL
    K160590 XN CHECK
    K141957 XN CHECK BF
    K141964 XN CHECK
    K141962 XN CAL
    Search all 33 clearances from Streck →