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

    Cell-Free DNA BCT

    K Number: K231776 · Decision Jul 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    3
    Review Days
    406

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    Basic Information

    Device Name
    Cell-Free DNA BCT
    K Number
    K231776
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1676
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Streck, Inc.
    Date Received
    June 16, 2023
    Decision Date
    July 26, 2024
    Product Code
    QMA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QMA Blood Collection Device For Cell-Free Nucleic Acid

    Similar 510(k) Clearances

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

    Cell-Free DNA BCT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
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    Other Clearances by Streck, Inc.

    K Number Device Name
    K212576 MDx-Chex for BCID2
    DEN200001 Cell-Free DNA BCT