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    FDA 510(k) FDA class 2 Unknown 🇦🇷 Argentina

    Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)

    K Number: DEN220042 · Decision Jul 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    8
    Review Days
    742

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    Basic Information

    Device Name
    Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
    K Number
    DEN220042
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    880.2806
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Terragene S.A.
    Date Received
    July 1, 2022
    Decision Date
    July 12, 2024
    Product Code
    QVB
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QVB Biological Sterilization Indicator With Indirect Growth Detection

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    Other Clearances by Terragene S.A.

    K Number Device Name
    K242453 Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
    K231383 Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
    K232103 Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
    K221641 Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
    K200272 Terragene Chemdye
    K191021 Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
    K163646 Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator