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

    MDx-Chex for BCY

    K Number: K254167 · Decision Mar 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    30
    Applicant Total
    2
    Review Days
    84

    Basic Information

    Device Name
    MDx-Chex for BCY
    K Number
    K254167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3920
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Streck, LLC
    Date Received
    December 23, 2025
    Decision Date
    March 17, 2026
    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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