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

    The SensiTox B. anthracis Toxin Test

    K Number: K232545 · Decision Nov 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    The SensiTox B. anthracis Toxin Test
    K Number
    K232545
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3046
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    First Light Diagnostics, Inc.
    Date Received
    August 22, 2023
    Decision Date
    November 20, 2023
    Product Code
    QUU
    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
    QUU Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

    Similar 510(k) Clearances

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

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    Other Clearances by First Light Diagnostics, Inc.

    K Number Device Name
    K193490 SensiTox C. difficile Toxin Test