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

    Active Anthrax DetectTM Plus Rapid Test

    K Number: DEN220044 · Decision Feb 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    7
    Review Days
    210

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    Basic Information

    Device Name
    Active Anthrax DetectTM Plus Rapid Test
    K Number
    DEN220044
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3046
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    InBios International, Inc.
    Date Received
    July 8, 2022
    Decision Date
    February 3, 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

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